BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3913025 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19083
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED EVIDENCE OF POWER ON RESETS. ON EXAMINATION, THE PUMP HAD VISIBLE MOISTURE IN THE DISPLAY LENS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THE THREADS DOWN TO THE CASE SEAL. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION; A TEST BATTERY CAP WAS USED TO COMPLETE THE INVESTIGATION. THE PUMP WAS POWERED ON WITH FUNCTIONAL AUDITORY ALARM. THERE WAS NO FUNCTIONING VIBRATORY ALARM. THE DISPLAY SCREEN DID NOT ILLUMINATE WHEN THE PUMP POWERED ON. A LEAK TEST WAS PERFORMED; THE PUMP FAILED THE LEAK TEST EVIDENCED BY MOISTURE LEAKAGE AT THE BATTERY COMPARTMENT CRACK. THE PUMP COVER WAS REMOVED FOR FURTHER INVESTIGATION REVEALING FURTHER MOISTURE DAMAGE TO THE INTERIOR COMPARTMENT AND COMPONENTS.

    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. 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 POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE; BATTERY COMPARTMENT CRACKED WITH MOISTURE BEHIND THE DISPLAY. 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
    391202 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR