BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3220896 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10309
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS NOT DUPLICATED DURING TESTING. DURING TESTING THE PUMP REWIND, LOAD, AND PRIME STEPS WERE COMPLETED SUCCESSFULLY AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND FOUND THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. EVALUATION REVEALED A CRACKED SOLDER JOINT AT THE FORCE SENSOR PINS AND REVEALED CONTAMINATION IN THE FORCE SENSOR ASSEMBLY. UNRELATED TO THE FORCE SENSOR ISSUE, THE DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED; THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL. 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. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR MULTIPLE LOSS OF PRIME WARNINGS. THE PUMP WAS INVESTIGATED AND FOUND A CRACKED SOLDER CONNECTION IN THE FORCE SENSOR CIRCUIT AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321109 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR