BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140110 · Received June 25, 2011

    Report

    Report Number
    2531779-2011-04459
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP PRIMED APPROPRIATELY AND WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIMES WARNINGS. THE PUMP BLACK BOX HISTORY INDICATED THAT LOSS OF PRIME WARNINGS WERE EMITTED AND ASSOCIATED WITH NON-ZERO LOW FORCES. THE PUMP CORRECTLY DETECTED THIS ISSUE AND EMITTED LOSS OF PRIME ALARMS TO ALERT THE USER.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF HI ON THE METER (OVER 600 MG/DL) WITH POSITIVE KETONES. THE FAMILY MEMBER REPORTED THAT THE PATIENT WOKE UP WITH A BG OF 378 MG/DL; THE PATIENT REPORTEDLY NOTICED A LOSS OF PRIME WARNING ON THE PUMP. THE FAMILY MEMBER REPORTED THAT THE PATIENT'S BG CONTINUED TO ELEVATE AND WAS UP TO HI BY 9 AM. THE FAMILY MEMBER CONFIRMED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURE CHANGES AND THE CARTRIDGE COMPARTMENT CAP IS ON TIGHT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention