BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2855112 · Received December 3, 2012

    Report

    Report Number
    2531779-2012-14189
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PUMP IS MALFUNCTIONING BECAUSE THERE ARE REPEATED OCCLUSION ALARMS. THE PATIENT STATED THE MOTOR SOUNDED LIKE IT WAS STRUGGLING DURING THE PRIME OPERATION. THE PATIENT WOULD NOT AGREE TO TRY NEW SITE/SET/CARTRIDGE DURING TROUBLESHOOTING, INSISTING THE PUMP WAS DEFECTIVE. THE PATIENT ALLEGED ELEVATED BLOOD GLUCOSE OF 334-472 MG/DL WITH VOMITING AS A RESULT OF THE OCCLUSIONS. THE PATIENT WAS ABLE TO LOWER THE BG WITH INJECTIONS AND REPORTED BG OF 81 MG/DL AT THE TIME OF THE CALL. THE PATIENT HAS DISCONTINUED USE OF THE INSULIN PUMP AND IS ON A BACKUP PLAN WITH SYRINGES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED AT THE CONCLUSION OF THE CALL AND THE PATIENT ALLEGED ELEVATED BG THAT QUALIFIED AS A REPORTABLE ADVERSE EVENT.

    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 42 YR Life Threatening| R