BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3914110 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19142
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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

    (B)(4). THE INITIAL MDR SUBMISSION WAS INADVERTENTLY REPORTED AGAINST THE PUMP. THERE WAS NO PUMP MALFUNCTION REPORTED. THE INFUSION SET WAS DETERMINED TO BE DEFECTIVE CAUSING THE PUMP TO EMIT AN ALARM AS PER NORMAL FUNCTION. ANIMAS DOES NOT MANUFACTURE INFUSION SETS. IF THE INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE FORWARDED TO THE RELEVANT MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. THE REPORTER ALLEGED THAT THE PUMP EMITTED AN OCCLUSION ALARM WHEN PERFORMING THE PRIME STEP. 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
    390778 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR