BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4222240 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31313
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 05/13/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/05/2016 WITH THE FOLLOWING FINDINGS: THERE WERE MULTIPLE OCCLUSION ALARMS OBSERVED IN THE BLACK BOX WITH THE FORCE BEING HIGH AT THE TIME. THE ORIGINAL COMPLAINT COULD NOT BE ADEQUATELY INVESTIGATED DUE TO A LOAD STEP MALFUNCTION. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED. ALSO UNRELATED, THE BATTERY CAP THREADS WERE STRIPPED AND IT WAS UNABLE TO SECURE TO THE PUMP. A TEST CAP WAS USED AND SECURED TO THE PUMP FOR TESTING. THE DISPLAY WAS OBSERVED TO BE DIM AND DISCOLORED. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A OCCLUSION (FREQUENT/PERSISTENT) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EMITTING OCCLUSION ALARMS FREQUENTLY. IT WAS NOTED THAT CHANGING THE TUBING WAS NOT ABLE TO RESOLVE THE OCCLUSION 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
    703127 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR