BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3903914 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18671
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 08/27/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: CS-054 CALL SERVICE ALARMS, FOLLOWED BY REBOOT EVENTS, WERE OBSERVED IN THE BLACK BOX DATA; THESE FINDINGS ARE INDICATIVE OF THE EVENT REPORTED IN THE INITIAL COMPLAINT. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS ABLE TO FULLY TIGHTEN TO THE PUMP; A POWER-LOSS EVENT WAS NOT OBSERVED DURING THE ANALYSIS. MEASUREMENTS OF THE BATTERY CAP CONTACT WERE WITHIN THE SPECIFICATIONS. THE INTERMITTENT-POWER EVENT REPORTED IN THE INITIAL COMPLAINT COULD NOT BE ADEQUATELY INVESTIGATED DUE TO AN UNRELATED PRIME-ISSUE. UNRELATED TO THE REPORTED EVENT, THE PUMP COULD NOT PRIME SUCCESSFULLY. THE PUMP FAILED A FORCE CALIBRATION CHECK AND PASSED A FORCE SENSOR RESISTANCE CHECK. THE PUMP CASE WAS REMOVED, AND THE FORCE SENSOR PINS WERE OBSERVED TO BE SEATED AND SOLDER CONNECTIONS INTACT. EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE FORCE SENSOR CIRCUITRY AND OTHER INTERNAL COMPONENTS.

    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 (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT A NEW BATTERY WAS INSERTED INTO THE PUMP, BUT WAS UNABLE TO RESOLVE THE POWER 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
    380188 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR