FDA Device

Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets.

Hazard

Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.

What You Should Do

Remedy

The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.

Products

Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets.
Brand
Animas Corporation
UPC
Part Number: 100-158-01. All units (no serial numbers).

Units Affected

1,388 caps