BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3830066 · Received May 23, 2014

    Report

    Report Number
    2531779-2014-14680
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE LOW CARTRIDGE WARNING HAD BEEN SET TO 20 UNITS. ALL LOW CARTRIDGE ALARMS WERE RECORDED AT OR BELOW THE SET AMOUNT. DURING INVESTIGATION THE LOW CARTRIDGE WARNING WAS SET TO 20 UNITS. THE UNIT WAS PRIMED TO JUST ABOVE 20 UNITS. THE AMOUNT IN CARTRIDGE WAS LOWERED AND THE WARNING OCCURRED AT PROPER SETTING. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A OTHER (UNUSUAL ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP GAVE A LOW CARTRIDGE WARNING WHEN THERE WAS INSULIN REMAINING. 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
    308757 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR