BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3912245 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19032
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 28, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/11/2014 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE UNDERSIDE OF THE BATTERY CAP. THE BATTERY CAP THREADS WERE DAMAGED, AND THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE PUMP DID NOT POWER ON. A TEST BATTERY CAP WAS USED TO POWER ON THE PUMP AND COMPLETE INVESTIGATION. A LEAK TEST WAS PERFORMED AND CONFIRMED A BATTERY COMPARTMENT LEAK. THE PUMP CASE WAS REMOVED AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT MOISTURE INGRESS WAS VISIBLE IN THE PUMP BATTERY COMPARTMENT. 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
    390898 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR