BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3844407 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15532
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 26, 2014
    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

    FOLLOW-UP #1: DATE OF SUBMISSION 07/16/2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/07/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND OCCURRENCES OF POWER ON RESET. THE BATTERY COMPARTMENT AND RETURNED BATTERY CAP WAS UNDAMAGED. THE CONTACT MEASUREMENTS OF THE BATTERY CAP WERE WITHIN SPECIFICATIONS. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENTS. THE PUMP CASING WAS OPENED AND NO INTERNAL ISSUES WERE FOUND WITH THE POWER CIRCUIT. THE REPORTED POWER ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED DURING THE INVESTIGATION.

    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. REPORTEDLY, THE PUMP HAD INTERMITTENT POWER ISSUE. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP, THE CAP WAS ABLE TO TIGHTEN PROPERLY AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. THE REPORTER NOTED THAT THE ISSUE WAS NOT RESOLVED WITH A NEW BATTERY. 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
    321374 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR