BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3831349 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14721
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    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

    FOLLOW-UP #1: DATE OF SUBMISSION 07/21/2014. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND OCCURRENCES OF UNEXPLAINED POWER ON RESET ON THE EVENT DATE. THE BATTERY COMPARTMENT AND CAP WERE INTACT. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENTS. ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE PUMP CASING WAS OPENED AND NO EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. THE REPORTED NO POWER ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE INVESTIGATION. UNRELATED TO THE REPORTED POWER ISSUE, IT WAS OBSERVED THAT THE VERIFY SCREEN WAS DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. REPORTEDLY, THE PUMP FAILED TO POWER UP. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THE CAP WAS ABLE TO SECURE PROPERLY. THE REPORTER STATED THAT THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP AND 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
    309645 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR