BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242750 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11728
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 11/05/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/24/2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO MOISTURE OBSERVED BEHIND THE DISPLAY LENS, BUT THE LEAK TEST DID SHOW A LEAK AT THE DISPLAY LENS. THE PUMP POWERED ON TO THE VERIFY SCREEN WITH NORMAL OPERATION. UNRELATED TO THE ORIGINAL COMPLAINT, THERE WAS A CRACK NEAR THE BATTERY COMPARTMENT, BUT NO EVIDENCE OF MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP, SO A TEST CAP WAS USED AND WAS FULLY ABLE TO BE TIGHTENED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OBSERVED. THERE WERE ALSO NO BATTERY RELATED WARNINGS OBSERVED. CONTAMINATION WAS FOUND INSIDE THE PUMP WHEN THE PUMP CASE WAS REMOVED. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 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 ISSUE INVOLVING MOISTURE INGRESS. AFTER THE BATTERY WAS REPLACED, THE KEYPAD BUTTONS WERE NO LONGER FUNCTIONAL. MOISTURE WAS NOTED UNDER THE DISPLAY. 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
    342501 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR