BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4151877 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28611
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: SHORTER THAN EXPECTED TIME FRAMES BETWEEN OCCURRENCES OF LOW BATTERY WARNINGS AND REPLACE BATTERY ALARMS, WHICH CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE BLACK BOX AND ALARM HISTORY DATA. HOWEVER, IT IS ALSO POSSIBLE THAT A PARTIALLY DISCHARGED BATTERY WAS INSTALLED FOR USE. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE GRIP PAD. EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE UNDERSIDE OF THE BATTERY CAP. EVALUATION REVEALED THAT THE PUMP DREW ELECTRIC CURRENT AT LEVELS WITHIN THE SPECIFICATIONS: THE REPORTED BATTERY-LIFE ISSUE WAS NOT DUPLICATED. THE PUMP PASSED A LEAK TEST. THE PUMP CASE WAS REMOVED, AND NO FURTHER EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. THE RELATION OF THE AFOREMENTIONED DEVICE FAILURES TO THE REPORTED BATTERY LIFE ISSUE CAN NOT BE DETERMINED, AS THE REPORTED BATTERY LIFE ISSUE WOULD HAVE TO BE DUPLICATED TO DETERMINE SUCH. UNRELATED TO THE REPORTED ISSUE, THE DISPLAY SCREEN VISUAL WAS FOUND TO BE DIM AND DISCOLORED DUE TO AN UNIDENTIFIED DISPLAY FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER ALLEGED THAT BATTERY LIFE WAS SHORTER THAN EXPECTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632418 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR