BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2153770 · Received July 7, 2011

    Report

    Report Number
    2531779-2011-04772
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 10, 2011
    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

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED AN INTACT KEYPAD WITH INTERMITTENTLY RESPONSIVE UP AND DOWN BUTTONS. THE CONTRAST BUTTON WAS UNRESPONSIVE. UPON REMOVAL OF THE KEYPAD COVER, CONTAMINATION WAS FOUND UNDER ALL CONTACTS. UNRELATED TO THE ORIGINAL COMPLAINT, THE AUDIO BOLUS BUTTON (ABB) WAS UNRESPONSIVE. NO DAMAGES WERE OBSERVED TO THE ABB COVER. UPON REMOVAL OF THE COVER, MOISTURE CONTAMINATION WAS FOUND INSIDE THE ABB COVER AND UNDER THE ABB CONTACT. ADDITIONALLY, THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN 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).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE UP ARROW BUTTON AND OK BUTTON DID NOT ACTIVATE DESIRED PUMP FUNCTIONS WHEN PRESSED. THERE WAS NO EVIDENCE OF MISUSE OF THE PRODUCT. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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