BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233772 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11289
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/21/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WOULD NOT POWER ON. MULTIPLE CRACKS WERE OBSERVED ALONG THE PUMP BATTERY COMPARTMENT AND CONTAMINATION DUE TO MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP COULD NOT BE FULLY TIGHTENED TO THE PUMP DUE TO THE CRACKS IN THE BATTERY COMPARTMENT, AND CONTAMINATION DUE TO MOISTURE WAS ALSO FOUND ON THE INTERNAL PORTION OF THE BATTERY CAP. A LEAK TEST WAS PERFORMED AND CONFIRMED A BATTERY COMPARTMENT LEAK. THE PUMP CASE WAS OPENED AND NO ADDITIONAL EVIDENCE OF MOISTURE WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT AFTER CHANGING THE BATTERY THE PUMP WOULD NOT POWER ON. IT WAS NOTED THAT THE PATIENT WENT SWIMMING OVER THE WEEKEND AND RECEIVED A WARNING FOR BATTERY REPLACEMENT. THE BATTERY CAP WAS LOOSE WHEN THE PATIENT WENT SWIMMING. WHEN THE BATTERY WAS REPLACED TODAY WATER WAS OBSERVED IN THE BATTERY COMPARTMENT. THE BATTERY CAP APPEARED TO BE LOOSE AND THE O-RING WAS VISIBLE. 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
    334398 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR