BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4418634 · Received January 14, 2015

    Report

    Report Number
    2531779-2015-01279
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Report Date
    December 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 03/17/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/25/2015 WITH THE FOLLOWING FINDINGS: ¿PUMP NOT PRIMED¿ WARNINGS WITH ZERO FORCE AND ¿NO CARTRIDGE DETECTED¿ WARNINGS OBSERVED IN THE BLACK BOX. DURING THE REWIND STEP THE PUMP GAVE ¿076-0001¿ ALARM. THE PUMP WAS OPENED; INTERNAL MOTOR FAILURE FOUND. NO DAMAGE FOUND TO FORCE SENSOR CIRCUIT. BATTERY CAP UNAVAILABLE FOR TESTING A TEST CAP WAS USED FOR TESTING PURPOSES.

    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
    33195 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1