BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241278 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11599
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013 WITH THE FOLLOWING RESULTS: AN UNACKNOWLEDGED ALARM OBSERVED IN BLACK BOX. BLACK BOX SHOWS AN UNCONFIRMED CALL SERVICE ALARM ¿OCCLUSION DURING PRIME¿ ON (B)(6) 2013 11:24. THE ALARM WENT UNCONFIRMED UNTIL (B)(6) 2013 12:48; THE BATTERY COMPLETELY DISCHARGED AND PUMP BEGAN TO CONTINUOUSLY REBOOT. PUMP POWERS ON WITH VIBRATORY AND AUDIBLE SOUNDS. PUMP WAS PROGRAMMED WITH A 1.0U/HR BASAL FOR A 24-HR DURATION PERIOD; NO EAW¿S WERE DUPLICATED DURING THIS TIME. PUMP CASE WAS REMOVED, NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE PUMP. NO EVIDENCE OF INTERMITTENT CONTACT WAS FOUND ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. IT WAS REPORTED THAT THE PUMP WOULD NOT POWER ON AFTER TURNING OFF CSA AUDIO ALARM. BATTERY WAS CHANGED, BUT IT DID NOT RESOLVE THE 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
    341760 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR