BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2962203 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01796
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    August 14, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/21/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED TWO "NO CARTRIDGE DETECTED" WARNINGS RECORDED IN HISTORY. THE PUMP POWERED UP WITH NO ISSUES. THE PUMP WAS FOUND NOT TO DETECT THE CARTRIDGE DURING THE LOAD STEP. A FORCE SENSOR CALIBRATION TEST WAS UNABLE TO BE PERFORMED DUE TO THE LOAD STEP FAILURE. THE PUMP WAS OPENED AND A COMPONENT WAS FOUND TO BE SHIFTED AND MISALIGNED ON THE PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PUMP ALLEGEDLY DISPENSED THE ENTIRE CARTRIDGE OF INSULIN. 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
    64467 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1