FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2211334
·
Received August 15, 2011
Report
- Report Number
- 2531779-2011-05872
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Report Date
- September 2, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
A FAMILY MEMBER REPORTED THAT THE OK KEYPAD BUTTON WAS NOT RESPONDING AS EXPECTED. SHE STATED THAT ON SEVERAL OCCASIONS THE PUMP CANCELLED BOLUSES WITHOUT USER INTERVENTION. SHE CONFIRMED THAT THE OTHER KEYPAD BUTTONS WERE FUNCTIONING APPROPRIATELY. THE FAMILY MEMBER DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |