BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230990 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11065
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PATIENT WAS DISCONNECTED AT THE SITE.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/21/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/24/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY VERIFIED A LOAD STEP MALFUNCTION AND A NO CARTRIDGE DETECTED WARNING 06/13/2013. ADDITIONALLY, THERE WERE THREE LOSS OF PRIME EVENTS VERIFIED. A LOAD STEP MALFUNCTION WAS DUPLICATED DURING TESTING. THE PUMP COVER WAS OPENED AND THE FORCE SENSOR PINS WERE FOUND TO HAVE A CRACKED SOLDER. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE RECEIVED THE LOSS OF PRIME WARNINGS THREE TIMES A DAY. THE PATIENT STATED THAT FIRST TWO LOSS OF PRIME WARNINGS, SHE DISCONNECTED AND SHE WAS ABLE TO PRIME 0.5 UNITS, THIRD LOSS OF PRIME OCCURRED, PATIENT STATED THAT SHE DID NOT DISCONNECT FROM SITE, BUT COMPLETED REWIND STEP AND WHEN SHE PUSHED OK TO LOAD CARTRIDGE, PUMP PUSHED UNKNOWN AMOUNT OF INSULIN INTO HER AS SHE WAS NOT DISCONNECTED. THE PATIENT STATED THAT WHEN SHE NOTICED WHAT WAS HAPPENING SHE DISCONNECTED. HER BLOOD GLUCOSE (BG) AT THIS WAS 260MG/DL AND A HALF HOUR LATER IT WAS 124MG/DL, SHE TREATED WITH ICE CREAM, KOOL-AID AND JUICE AND THEN WENT TO THE HOSPITAL. PATIENT STATED THAT SHE HAS BEEN TREATED IN EMERGENCY DEPARTMENT ONLY, NO IVS STARTED AND HAS BEEN CONSUMING JUICE. PATIENT STATES LOWEST BG WAS 93MG/DL AND MOST RECENT BGS WERE 125MG/DL AND 137MG/DL. THE PATIENT WAS DISCONNECTED AND THE IFU STATES THE PATIENT TO DISCONNECT DURING LOAD STEP. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331781 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization