BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2910969 · Received January 11, 2013

    Report

    Report Number
    2531779-2013-00543
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 25, 2012
    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

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    (B)(4):THERE WAS NO EVIDENCE OF A LOAD STEP MALFUNCTION RECORDED IN THE BLACK BOX. THE BLACK BOX DID RECORD MULTIPLE OCCLUSIONS FOLLOWED BY LOSS OF PRIME WITH HIGH FORCE. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED WITH NO LOSS OF PRIME OCCURRING. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. THERE WAS NO DEFECT FOUND TO THE FORCE SENSOR CIRCUITS.

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) 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
    18940 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1