ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2013-01451
- Event Type
- Injury
- Date Received
- February 3, 2013
- Date of Event
- January 12, 2013
- Report Date
- January 15, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.
(B)(4) - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND PUMP HISTORY WERE DOWNLOADED FOR EXAMINATION. THE DATE OF THE PATIENT EVENT WAS REPORTED TO BE (B)(6) 2013. THE PUMP CONTINUED TO BE USED UNTIL THE LAST BASAL DELIVERY RECORD ON (B)(6) 2013 AT 10:14AM. THE BLACK BOX SHOWED A BASAL DELIVERY INTERRUPTION AS A RESULT OF POWER INTERRUPTION BETWEEN (B)(4) 2013 AT 01:50AM AND (B)(4) 2013 AT 07:00PM. AS A RESULT THE TOTAL DAILY DOSE (TDD) SHOWED BASAL RATE FOR THAT TIME PERIOD TO BE BELOW THE PROGRAMMED RATE. OTHERWISE THE TDD ADDED UP CORRECTLY AND REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP POWERED "ON" AND DISPLAYED THE "VERIFY" SCREEN AS EXPECTED. THE PUMP WAS EXERCISED FOR 24 HOURS SUCCESSFULLY; NO ALARM WAS DUPLICATED DURING TESTING. THE BATTERY COMPARTMENT WAS UNDAMAGED, THE BATTERY CAP'S THREADS WERE INTACT, AND THE CAP WAS ABLE TO MAINTAIN ELECTRICAL CONNECTION. NO REBOOTS OCCURRED DURING TESTING. THE PUMP PASSED A 29-HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION; NO MOISTURE INGRESS WAS FOUND. THE POWER-FLEX AND FORCE SENSOR CIRCUIT WAS TESTED AND NO DEFECTS WERE FOUND. IN SUMMARY THE PUMP DISPLAYED NO ISSUES THAT MIGHT HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED PATIENT EVENT.
THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING HE HAD EXPERIENCED LOW BLOOD GLUCOSE (BG) ON (B)(6) 2013 OF 31 MG/DL ACCOMPANIED BY EXTREME SWEATING AND EXTREME DISORIENTATION. THE PATIENT REPORTED THAT HE WAS TAKEN TO THE HOSPITAL BY A FAMILY MEMBER WHERE HE WAS TREATED WITH A GLUCAGON INJECTION AND DISCONTINUED FROM INSULIN PUMP THERAPY (IPT). THE PATIENT REPORTED THAT HIS BG ELEVATED TO 94 MG/DL, BUT THEN DROPPED AGAIN TO 47 MG/DL AT WHICH POINT HE WAS GIVEN A SECOND INJECTION OF GLUCAGON. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT REPORTED HIS BG AS 128/MG/DL. THE PATIENT REPORTED THAT HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 AND WAS TREATED WITH INSULIN INJECTIONS AS NEEDED USING A SLIDING SCALE AND DISCHARGED (B)(6) 2013 AFTER RESUMING IPT. THE PATIENT REPORTED THAT THE DAY PRIOR TO EXPERIENCING THE LOW BG OF 31 MG/DL, HE HAD RECEIVED A FLU IMMUNIZATION AND EXPERIENCED SEVERE NAUSEA AND DIARRHEA AS A RESULT. THE PATIENT REMAINED ON INSULIN PUMP THERAPY DURING THAT TIME WITHOUT SETTING ADJUSTMENTS TO COMPENSATE FOR THE NAUSEA AND DIARRHEA. THE PUMP WAS REVIEWED BY ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) AND ALL SETTINGS WERE CONFIRMED TO BE SET AS DESIRED AND NO MALFUNCTION FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE ACTS DETERMINED THE PATIENT'S BG EXCURSION WAS DUE TO DISEASE MANAGEMENT ISSUES RESULTING FROM IMPROPER TECHNIQUE BY CONTINUING IPT USING NORMAL SETTINGS DURING A PERIOD OF ILLNESS INVOLVING NAUSEA AND DIARRHEA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45745 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| L |