BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4092381 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26353
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/24/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS POWER ON RESET ON (B)(6) ASSOCIATED WITH CARTRIDGE CHANGE AND ON (B)(6) AFTER AN ALARM. BATTERY COMPARTMENT IS CRACKED FROM THREADS TO COVER. NO DAMAGE FOUND TO RETURNED BATTERY CAP. RETURNED BATTERY CAP IS ABLE TO CAREFULLY ATTACH TO THE PUMP; PUMP BOOTS TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. A 24HR DURATION TEST WAS COMPLETED WITH RETURNED BATTERY CAP AND RETURNED CARTRIDGE CAP; RESETS WERE DUPLICATED. REMOVED PUMP COVER; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAS A PINKISH CONTRAST.

    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 (DAMAGE) 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
    573235 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR