BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780991 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11972
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/09/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/01/2014 WITH THE FOLLOWING FINDINGS: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. A REVIEW OF THE PUMP TOTAL DAILY DOSE HISTORY INDICATED THAT THE INACCURACY ON THE ALLEGED FAILURE DATE WAS DUE TO AN EXTENDED COMBO BOLUS SETTING WITH A DURATION OF EIGHT HOURS. THIS EXTENDED COMBO BOLUS WAS SET WITHIN THREE HOURS OF MIDNIGHT; THEREFORE, PART OF THE BOLUS WAS RECORDED ON THE DAY IT BEGAN, AND THE REST ON THE NEXT DAY. A DELIVERY ACCURACY TEST WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH ACCURATE DELIVERIES WITHIN THE REQUIRED RANGE. THE COMPLAINT WAS NOT DUPLICATED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE RECORDED BOLUS HISTORY AMOUNTS DID NOT ADD UP TO THE BOLUS VALUE FOR THE TOTAL DAILY DOSE. THE BASAL HISTORY ALLEGEDLY REFLECTED THE ACTIVE SETTINGS CORRECTLY AND TOTALED AS EXPECTED. 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
    260438 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR