BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4090675 · Received September 15, 2014

    Report

    Report Number
    2531779-2014-26305
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX WAS REVIEWED AND SHOWED EVIDENCE THAT THE TIME AND DATE HAD RESET TO DEFAULT AFTER A POWER EVENT THAT OCCURRED ON (B)(4) 2014. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS AND THEN THE BATTERY WAS REMOVED FOR 6 HOURS AND THE TIME AND DATE WERE FOUND TO HAVE RESET TO DEFAULT. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND THE INTERNAL PUMP BATTERY WAS FOUND TO BE LEAKING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS REPORTING A BLOOD GLUCOSE OF 0.85 MMOL/L RESULTING IN UNRESPONSIVENESS AND REQUIRING AN INJECTION OF GLUCAGON. THE REPORTER INDICATED THAT THE PUMP TIME AND DATE HAD RESET TO DEFAULT WHEN THE PUMP BATTERY WAS REMOVED. IT IS UNCLEAR IF THE PATIENT HAD CORRECTED THE TIME AND DATE ON THE PUMP¿S VERIFY SCREEN WHEN THE PUMP WAS REBOOTED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA WHICH MAY HAVE BEEN CONTRIBUTED TO BY USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570038 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening