BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2083373 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03294
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2, 07/20/2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON 06/22/2011 WITH THE FOLLOWING FINDINGS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 06/24/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/26/2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO PRESSES. THE KEYPAD WAS REMOVED AND NO DEFECTS WERE FOUND WITH THE BUTTON CONTACTS. A REVIEW OF THE BOLUS HISTORY SHOWED TWO 0.00 UNIT BOLUSES AT 05:34 AND 13:40. DURING EVALUATION, THE PUMP DELIVERED A 10 UNIT NORMAL BOLUS FROM THE PUMP MENU AND THE PUMP ACCURATELY RECORDED THE BOLUS IN THE HISTORY.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS AND THAT THE PUMP'S BOLUS HISTORY WAS MISSING INTERMITTENTLY. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH EITHER OF THESE COMPLAINTS. DURING TROUBLESHOOTING, THE REPORTER CLAIMED THE OK KEYPAD BUTTON IS INTERMITTENTLY UNRESPONSIVE WHEN PRESSED. THE PATIENT'S MOTHER CLAIMED THE BUTTON WAS HARD TO PRESS AND WOULD ALSO STICK. THE PATIENT'S MOTHER DENIED ANY DAMAGE TO THE KEYPAD. DURING THE CALL, THE PATIENT'S MOTHER ALSO REPORTED THAT INTERMITTENTLY WHEN REVIEWING THE BOLUS HISTORY IN THE PUMP SCREENS WERE SKIPPED. THE REPORTER CLAIMED ON (B)(6), 2011 WHILE REVIEWING THE BOLUS HISTORY, THE PUMP WOULD SKIP FROM RECORD 1 TO 3 TO 5 AND NOT GO IN SEQUENTIAL ORDER. AT THE TIME OF TROUBLESHOOTING, THE REPORTER CONFIRMED THAT ALL BOLUSES ADMINISTERED ON (B)(6) 2011 (EXCEPT FOR 2) THAT APPEARED IN THE PUMP'S BOLUS HISTORY MATCHED WHAT WAS DOCUMENTED IN THE REPORTER'S LOGBOOK. TWO ENTRIES OF 0.00 UNITS ON (B)(6) 2011 WERE NOT CAPTURED IN REPORTER'S LOGBOOK.

    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