BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4091794 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26350
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: THERE WERE PUMP REBOOTS OBSERVED IN THE BLACK BOX HISTORY ON (B)(6) 2014 IN REFERENCE WITH CLEARING ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOTS, LOSS OF POWER, OR CALL SERVICE ALARMS DUPLICATED. THERE WAS NO INTERMITTENT POWER EVENT DUPLICATED DURING INVESTIGATION. THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WHEN THE PUMP CASE WAS REMOVED. THE BATTERY CAP WAS NOT RETURNED, SO A TEST CAP WAS USED FOR ALL TESTING. THE TEST CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP AND A POWER LOSS WAS NOT OBSERVED. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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
    573750 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR