BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183356 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05441
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    THE REPORTER CLAIMED THE ANIMAS PUMP WILL NOT POWER ON. THE BATTERY WAS REPLACED BUT THE SUBJECT PUMP GETS THE VERIFY SCREEN, THEN BEEPS AND SHUTS OFF. THE PATIENT HAS BEEN ON THE BACKUP PLAN FOR ONE MONTH SINCE THE ONSET OF THE POWER ISSUE. THE BATTERY WAS REPLACED BUT THE POWER ISSUE WAS NOT RESOLVED. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THERE WAS NO DAMAGE TO THE BATTERY CAP OR COMPARTMENT. THIS WAS NO PRODUCT MISUSE. THE BATTERY COMPARTMENT DID NOT HAVE CORROSION. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR