BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4112834 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27204
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 10, 2014
    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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A LOSS OF PRIME ASSOCIATED WITH A LOW, NON-ZERO FORCE. DURING TESTING, THE PUMP WAS POWERED ON AND IMMEDIATELY EMITTED A CS 064 CALL SERVICE ALARM; FURTHER TESTING OF THE PRIME ISSUE COULD NOT BE COMPLETED DUE TO THE ALARM. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON COVER WAS OBSERVED TO BE MISSING, AND CORROSION WAS PRESENT AMONG THE INTERNAL COMPONENTS OF THE BUTTON. A LEAK TEST WAS PERFORMED AND FAILED DUE TO THE MISSING BOLUS BUTTON COVER. ADDITIONALLY, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE PUMP CASE WAS REMOVED AND FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (UNABLE TO PRIME) 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
    595582 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1