BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3850087 · Received June 4, 2014

    Report

    Report Number
    2531779-2014-15799
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    June 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS WITH RETUNED BATTERY CAP. BATTERY CAP ABLE TO FULLY TIGHTEN. BATTERY COMPARTMENT CRACK OBSERVED BELOW GRIP PAD. ONE EAW 128-FB80 ALARM AND MULTIPLE EAW 128-FE80 ALARMS OBSERVED IN BLACK BOX ON (B)(6) 2014. DURING INVESTIGATION, PERFORMED MULTIPLE ¿LOAD STEP¿ FUNCTIONS. NO EAW'S DUPLICATED. THE CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE PUMP, ON TRANSCEIVER BOARD. 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.

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (128-FXXX) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326286 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR