BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3122078 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06792
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/24/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP DID NOT POWER ON. THE PUMP HAD A BLANK DISPLAY, NO AUDIBLE TONE, NO VIBRATION ALARM, AND THE PUMP WAS UNRESPONSIVE DUE TO INTERNAL MOISTURE CONTAMINATION. DURING INVESTIGATION, THE PUMP WAS REMOVED FROM THE CASE AND THE FORCE SENSOR WIRE WAS FOUND TO BE TO BE CRACKED AT THE FORCE SENSOR PIN. UNRELATED TO THE FORCE SENSOR ISSUE, A LEAK TEST WAS PERFORMED AND SHOWED LEAK AT THE DISPLAY LENS. ADDITIONALLY, THERE WAS EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT THE PUMP DISPENSED ALL OF THE INSULIN OUT OF THE CARTRIDGE AND EMITTED A NO CARTRIDGE DETECTED ALARM. 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
    223913 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR