BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3885348 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17705
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX HISTORIES ONLY EXISTED BETWEEN (B)(6) 2014 AND (B)(6) 2014. THE PUMP HISTORIES SHOWED THAT ON (B)(6) 2014 MULTIPLE CALL SERVICE ALARMS WERE RECORDED. THE PUMP WAS EXERCISED FOR 24 HOURS AT 1 UNIT/HOUR WITH NO CALL SERVICE ALARMS OR OTHER WARNINGS BEING OBSERVED. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE CUSTOMER COMPLAINT. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS OBSERVED TO BE A DIM RED COLOR UPON START UP. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. THE REPORTER STATED THAT A CALL SERVICE ALARM OCCURRED DURING THE PRIME STEP. 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
    361452 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR