BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4152976 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28633
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 11/17/2014 WITH THE FOLLOWING FINDINGS: AN INEXPLICABLE POWER-REBOOT EVENT, WHICH CAN BE INDICATIVE OF THE TYPE OF POWER ISSUE THAT WAS REPORTED, WAS OBSERVED IN THE BLACK BOX DATA. ALSO, A CS-054 CALL SERVICE ALARM, WHICH CAN CAUSE A BLANK DISPLAY AND THUS BE MISTAKEN FOR A POWER ISSUE, WAS ALSO OBSERVED IN THE BLACK BOX DATA. THE THREADS OF THE BATTERY CAP WERE DAMAGED. THE BATTERY COMPARTMENT WAS CRACKED IN THE THREAD AREA AND BELOW THE GRIP PAD. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS UNABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU) DUE TO THE BATTERY COMPARTMENT AND CAP DAMAGE. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO POWER-RELATED EVENTS WERE OBSERVED: THE REPORTED POWER ISSUE WAS NOT DUPLICATED. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. THE RELATION OF THE AFOREMENTIONED DEVICE FAILURES TO THE REPORTED POWER ISSUE CAN NOT BE DETERMINED, AS THE REPORTED POWER ISSUE WOULD HAVE TO BE DUPLICATED TO DETERMINE SUCH. UNRELATED TO THE REPORTED POWER ISSUE, THE DISPLAY SCREEN VISUAL WAS DIM AND DISCOLORED DUE TO AN UNIDENTIFIED DISPLAY FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EXPERIENCING A NO-POWER ISSUE. REPORTEDLY, THE POWER ISSUE WAS OCCURRING DURING OR IMMEDIATELY AFTER A BATTERY CHANGE. 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
    631489 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR