Animas 2020 Recall

From the FDA: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm?source=govdelivery

Animas Corporation 2020 Insulin Infusion Pump: Class I Recall - False Alarm or Warning Sound 

[Posted 04/05/2013]
AUDIENCE: Risk Manager, Patient 

ISSUE: Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: 

• “Loss of prime”

• “Occlusion”

• “No Cartridge detected” 

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia. 

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no linger deliver insulin and will generate a “Call Service Alarm.” 

BACKGROUND: The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes. 

RECOMMENDATION: Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

• Download form
 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/05/2013 - Recall Notice - FDA]

Verio Recall

LifeScan has announced a voluntary removal and replacement of the OneTouch® Verio®IQ blood glucose meter, effective immediately.

The reason:

We have recently determined that at extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch® Verio®IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 600 mg/dL” as intended. 

I think that there might be other issues at 1,024 but YDMV. At any rate see the details and act accordingly. Maybe most important of acting accordingly,  is to stay out of the extremely high range.

Statement from Bayer on Contour Strip Recall

I just received this statement form Bayer: 

BAYER HEALTHCARE RECALLS 10-COUNT and 25-COUNT VIALS OF BLOOD GLUCOSE TEST STRIPS IN UNITED STATES

US Action Follows Stop-Ship That Began in June


Tarrytown, NY --Bayer HealthCare confirmed today that it is recalling all 10- and 25- count Contour strips and 10-count Contour TS test strips from US retail stocks, retail distribution channels and offices of US healthcare professionals. The FDA is aware of this action.

These actions are not taken as a result of any adverse events reported to Bayer.  Instead, Bayer is taking this action out of an abundance of caution to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing. In the FDA’s view, this deviation from US-approved specifications constituted a technical violation that required a field corrective action under US regulations.

50-count vials of Contour test strips are not affected, and strips used with Bayer’s Breeze™2 blood glucose meters are not affected.

This action follows Bayer’s decision in late June to stop new shipments of products containing the small-count vials of these test strips world-wide.  And with no new shipments of small count vials into the market since that time, we believe remaining unused quantities of potentially affected product in the market are likely very small.

While it resolves this issue, Bayer has increased its stocks of 50-count vials and is using these to fulfill new orders to ensure continued, uninterrupted market access to unaffected strips.

Contact:

Susan Yarin
Bayer HealthCare
(914) 366-1738
susan.yarin@bayer.com