BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5092969 · Received September 21, 2015

    Report

    Report Number
    2531779-2015-33795
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/21/2105 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: LOSS OF PRIME WARNINGS WERE OBSERVED IN THE PUMP'S BLACK BOX WHERE THE FORCE READINGS DID NOT REACH ZERO. THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THAT THE SENSOR WAS DETECTING THE CORRECT FORCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIMES OCCURRING. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT NOT YET EVALUATED. WHEN THE DEVICE EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WERE MULTIPLE LOSS OF PRIME WARNINGS WITH DIFFERENT CARTRIDGES. 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
    623815 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR