BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3181527 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08713
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    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 WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWED LOSS OF PRIME WITH ZERO FORCE. THE CASE WAS CRACKED BETWEEN THE LENS AND CASE SEAL ON THE LOWER RIGHT SIDE OF DISPLAY. NO VISIBLE MOISTURE. PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO LOSS OF PRIME. ATTEMPTED TO EXERCISE PUMP FOR 24 HRS. ON A 1 UNIT PER HOUR BASAL PROGRAM RECEIVED A LOSS OF PRIME ALARM. FORCE SENSOR CALIBRATION WAS NOT IN SPECIFICATIONS, LOW OPENED PUMP AND REMOVED FROM CASE. MOISTURE IN PUMP AND CORROSION NOTED ALONG SIDE THE INTERNAL BATTERY CASE AND FORCE SENSOR. REMOVED FORCE SENSOR FROM PUMP. FORCE SENSOR WAS CORRODED. FORCE SENSOR RESISTANCE WAS HIGH. 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

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CRACKED PUMP CASE AND MOISTURE AND CORROSION IN THE PUMP. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281878 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1