BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3142782 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07499
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    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

    FOLLOW-UP #1 DATE OF SUBMISSION 07/24/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BOLUS BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED HARD PRESSES TO ELICIT A RESPONSE. THE BOLUS BUTTON HAD A HOLE ON THE COVER. REMOVED BUTTON COVER AND FOUND THE INTERNAL PLUG CONTACT IS MISALIGNED AND CONTAMINATION IS PRESENT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (AUDIO BOLUS BUTTON TACTILE CHANGE) ISSUE. THE REPORTER STATED THE AUDIO BOLUS BUTTON WAS DIFFICULT TO PRESS, REQUIRED MULTIPLE PRESSES, AND AT TIMES WOULD CAUSE A BOLUS TO NOT BE DELIVERED. THE REPORTER ALLEGED THE BLOOD GLUCOSE (BG) LEVEL WENT TO 18 MMOL/L WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE REPORTER NOTED AN INDENT IN THE AUDIO BOLUS BUTTON DUE TO HARD BUTTON PRESSES. 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
    244538 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR