BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4111573 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27186
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 12, 2014
    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

    FOLLOW-UP # 1 DATE OF SUBMISSION 8/15/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 7/20/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE BLACK BOX DATA AND HISTORIES FROM THE TIME OF THE ALLEGED INCIDENT WERE OVERWRITTEN THEREFORE THEY WERE UNAVAILABLE FOR REVIEW DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE INSULIN ON BOARD WAS FOUND TO FUNCTIONING PROPERLY BUT THE PUMP INFORMATION FOR THE COMPLAINT DATE WAS OVERWRITTEN THEREFORE THE INVESTIGATION WAS UNABLE TO DUPLICATE THE INITIAL COMPLAINT ABOUT AN ¿INACCURATE DELIVERY¿ ISSUE. UNRELATED TO THE INITIAL ALLEGATION, IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS CRACKED ABOVE THE BUMPER PAD. 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. (B)(4).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INACCURATE DELIVERY) 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
    591403 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR