BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242206 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11665
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/22/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/09/2013 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP POWERED ON NORMALLY WITH AUDITORY AND VIBRATORY SOUNDS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS. A 10U NORMAL AND A 10U AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. AN EZ BG BOLUS WAS ALSO SUCCESSFULLY PERFORMED AND RECORDED IN THE PUMP¿S HISTORY; THE PUMP¿S SOFTWARE SHOWED THE CORRECT BG VALUES. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THERE WERE RECORDS OF BG MEASUREMENTS AND BOLUSES MISSING FROM THE PUMP HISTORY FOR ½ DAY. THE REPORTER DENIED PATIENT NON-COMPLIANCE WITH THERAPY AND ALLEGED A PUMP ISSUE. THE REPORTER CONFIRMED THAT BOLUSES ARE ADMINISTERED VIA THE PUMP. (B)(4) CONFIRMED THE ALLEGATION WAS NOT A SOFTWARE ISSUE AND THAT IT IS PRINTING OUT, BUT THERE IS DATA MISSING, PARTICULARLY IN THE BOLUS HISTORY. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGATION OF MISSION INFORMATION FROM THE PUMP HISTORY REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342423 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR