Device product
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
Z-2082-2015
Product summary
- Event
- Event 70783
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225 units
- Official record key
device-enforcement:Z-2082-2015
Official wording
Reason: The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
Code information: Lot 7JH, UPC Code 384703800014
Distribution pattern: Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Derived failure modes
-
Unknown
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.