BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113511 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06108
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE EXPERIENCED A LOW BLOOD GLUCOSE (BG) OF 53MG/DL WITH INABILITY TO FOCUS AFTER INTENTIONALLY PRIMING WHILE ATTACHED. THE PATIENT REPORTED RECURRING LOSS OF PRIME WARNINGS, AND WAS FRUSTRATED WITH HAVING TO RE-PRIME THE PUMP, AND STATED SHE PRIMED TWO UNITS WHILE ATTACHED. THE PATIENT REPORTEDLY ATE CANDY TO RESOLVE THE LOW BG. THE PATIENT STATED THAT HER LAST CARTRIDGE CHANGE WAS A DAY AND A HALF AGO AND THE LOSS OF PRIME ISSUE HAS OCCURRED SINCE THEN. THE PATIENT WAS ADVISED TO CHANGE THE CARTRIDGE AND CONTACT ANIMAS IF THE ISSUE RECURS. THE PATIENT STATED THAT SHE KNOWS SHE IS NOT SUPPOSED TO PRIME WHILE ATTACHED AND NORMALLY DISCONNECTS, BUT NOTED THAT SHE WAS FRUSTRATED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA AFTER PRIMING WHILE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215504 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening