BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 5365586 · Received January 13, 2016

    Report

    Report Number
    2531779-2016-01440
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Report Date
    December 31, 2015
    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

    FOLLOW-UP #1 DATE OF SUBMISSION 05/24/2016 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/29/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX DATA SHOWED A CALL SERVICE 006 ALARM, INDICATING ¿END OF LIFE¿ FOR THE 2020 PUMP TIME/DATE SETTING 2 MIN POST (B)(6) 2015@11:58PM. A ¿DISCONTINUATION LETTER NOTIFICATION¿ WAS SENT TO ANIMAS 2020 CUSTOMERS ON 12/2012 EXPLAINING THE END OF SUPPORT OF ANIMAS 2020 PUMP AND UPGRADE OPTIONS. THE TIME AND DATE WAS SET OUT OF END OF LIFE SETTINGS AND THE PUMP SUCCESSFULLY PERFORMED THE EZ PRIME STEPS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. THE PUMP COVER WAS REMOVED AND NO INTERNAL DAMAGED WAS FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS 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. (B)(4).

    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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A 006-0001 CALL SERVICE 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
    23226 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR