BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3804004 · Received May 10, 2014

    Report

    Report Number
    2531779-2014-13142
    Event Type
    Injury
    Date Received
    May 10, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4)-PRODUCT ANALYSIS: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED DURING INVESTIGATION. A REVIEW OF THE PUMP¿S BLACK BOX AND HISTORY REVEALED NO RELATED ISSUES. THE TOTAL DAILY DOSE HISTORY MATCHED THE PROGRAMMED BASAL RATES. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. A DELIVERY ACCURACY TEST FOUND THE PUMP TO BE DELIVERING WITHIN SPECIFICATION. NO DAMAGE OR DEFECT WAS FOUND TO MOTOR RELATED COMPONENTS. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PATIENT¿S BLOOD GLUCOSE (BG) WAS BETWEEN 250-499 MG/DL BLURRED VISION, POLYDYPSIA, AND POLYURIA. IT WAS REPORTED THE PUMP WAS EMITTING AN UNUSUAL CLICKING MOTOR NOISE. THE PATIENT REMAINED ON THE PUMP FOLLOWING THE BG EXCURSION. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED SERIOUS INJURY AND ASSOCIATED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282829 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening