BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3872214 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16806
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 9, 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/07/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX REVIEW SHOWS EAW-162 LOSS OF PRIME WARNING ASSOCIATED WITH A LOW NON-ZERO FORCE. AN EZPRIME SEQUENCE AND 24HR DURATION TEST WERE SUCCESSFULLY COMPLETED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. THE FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS DETECTING THE CORRECT FORCE. REMOVED PUMP COVER; NO CONTAMINATION OR DAMAGE TO THE FORCE SENSOR CIRCUIT WAS OBSERVED. UNIDENTIFIED FORCE LOW OBSERVED IN THE BLACK BOX, FORCE SENSOR CALIBRATION IN SPECIFICATIONS. THE BATTERY COMPARTMENT IS CRACKED BELOW BUMPER GRIP. RETURNED BATTERY CAP IS ABLE TO FULLY TIGHTEN TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) 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
    349768 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR