ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2012-14057
- Event Type
- Injury
- Date Received
- November 29, 2012
- Report Date
- October 30, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS REGARDING ALARMS HE WAS RECEIVING WITH HIS PUMP. DURING THE CALL, THE PATIENT REPORTED HE HAS BEEN HOSPITALIZED FOR TIMES FOR BLOOD GLUCOSE (BG) RELATED ISSUES. THE PATIENT STATED THE FIRST HOSPITALIZATION WAS FOR A LOW BG. THE PATIENT STATED HE WAS TAKING NARCOTICS PRESCRIBED FOR TOOTH PAIN AND THAT HE WOKE UP THE NEXT DAY AT A FRIEND'S HOME AND WAS COLD AND DIAPHORETIC. EMERGENCY SERVICED WAS CONTACTED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT REPORTED THAT HIS BG WAS 28 MG/DL AND AT THE HOSPITAL WAS TAKEN OFF THE PUMP AND PLACED ON GLUCOSE DRIP. THE PATIENT STATED HE WAS HOSPITALIZED FOR 4 DAYS. THE PATIENT STATED THAT 4 DAYS LATER HE HAD A HIGH BG EXCURSION. THE PATIENT INFORMED CUSTOMER SUPPORT THAT HIS METER READ "HIGH" MULTIPLE TIMES. THE PATIENT WENT BACK TO THE HOSPITAL WHERE HE WAS ADMITTED FOR ANOTHER 5 DAYS AND WAS TREATED WITH INSULIN DRIP. CUSTOMER SUPPORT NOTED THAT THE OTHER 2 HOSPITALIZATIONS WERE ALSO FOR A HIGH BG EXCURSION. THE PATIENT DID NOT RECALL THE DATES OF THOSE HOSPITALIZATIONS OR THE DETAILS OF THE STAY. AT THE TIME OF THE CALL, THE PATIENT CONFIRMED HE WAS STILL CURRENTLY ON THE PUMP AND HIS CURRENT BG WAS 97 MG/DL AND FELT FINE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED ALL PUMP SETTINGS WERE CORRECT. REVIEW OF PRIME HISTORY REVEALED A PRIME AND FILL CANNULA EVERY 4 DAYS. CUSTOMER SUPPORT EXPLAINED TO THE PATIENT THAT IT IS NOT RECOMMENDED TO USE INFUSION SETS GREATER THAN 3 DAYS. THE PATIENT STATED HE WAS AWARE OF RECOMMENDATION; HOWEVER, WAS RUNNING LOW ON INFUSION SETS DUE TO CHANGING MORE FREQUENTLY THAN EXPECTED FOR HIGH BG'S. AT THE TIME OF THE CALL, THE PATIENT INFORMED CUSTOMER SUPPORT THAT HE SUFFERED A STROKE APPROXIMATELY 4 MONTHS PRIOR AND SINCE THEN HAS HAD A VERY DIFFICULT TIME. THE PATIENT CLAIMED THAT THE RESIDUAL EFFECTS OF THE STROKE CAUSE HIM HARDSHIP WITH PROCESSING THOUGHT AND OTHER COGNITIVE ISSUES AND MANAGING HIS DIABETES. THE PATIENT ALSO INFORMED CUSTOMER SUPPORT THAT HIS SLEEP WAKE PATTERN CHANGED WHEN HE BEGAN TAKING A ANTI-DEPRESSION MEDICATION AND THAT HE WAS VERY STRESSED DUE TO FINANCIAL ISSUES AND HAVING VERY LIMITED FAMILY SUPPORT. THIS COMPLAINT IS BEING REPORTED BASED ON THE INDICATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA ON MULTIPLE OCCASIONS AND INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.
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 | 54 YR | Hospitalization| L| R |