BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2753426 · Received September 20, 2012

    Report

    Report Number
    2531779-2012-10973
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 11/16/2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR PUMP HISTORIES. THE PUMP POWERED ON WITH UNRESPONSIVE KEYPAD BUTTONS. THE ALLEGED LOAD STEP MALFUNCTION COULD NOT BE ADEQUATELY INVESTIGATED DUE TO UNRESPONSIVE KEYPAD BUTTONS. THE PUMP WAS OPENED AND THERE WERE NO INTERNAL COMPONENT DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 SUBMITTED: 11/23/2012 DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201778 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. 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) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP DID NOT RECOGNIZE THE FILLED CARTRIDGE DURING THE LOAD STEP, AND GAVE A "NO CARTRIDGE DETECTED" MESSAGE. ALL OF THE INSULIN WAS PUSHED OUT OF THE CARTRIDGE. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1