BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4171731 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29229
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/22/2014 - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/03/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THERE WERE MULTIPLE 064 MOTOR ERRORS OBSERVED IN THE PUMP'S BLACK BOX ON (B)(4) 2014. THE ERRORS OCCURRED DURING THE "LOAD" SEQUENCE. DURING INVESTIGATION, A HARD 064 MOTOR ERROR WAS RECEIVED ON EACH "LOAD" ATTEMPT. INVESTIGATION COULD NOT BE COMPLETED AS A RESULT OF THIS ALARM. THERE WAS NO EVIDENCE OF MOISTURE INSIDE THE PUMP. FURTHER INVESTIGATION SHOWED AN INTERNAL MOTOR FAILURE CAUSING THE 064 MOTOR ERRORS. THE MOTOR WAS REMOVED FROM PUMP AND THE FAILURE WAS DUPLICATED ON A TEST FIXTURE. 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 THAT THE PUMP EMITTED A CALL SERVICE 064 ALARM. 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
    650331 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR