BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2963914 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01846
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY SHOWS THE PUMP WAS NOT IN USE BETWEEN (B)(6) 2012 AND (B)(6) 2013. A MANUAL TIME AND DATE CHANGE WAS NOTED IN THE BLACK BOX HISTORY FROM (B)(6) 2013, 9:23AM TO (B)(6) 2013, 9:22AM. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS; NO UN-PROGRAMMED BOLUSES WERE RECORDED IN PUMP HISTORY. A 10 UNIT NORMAL AND A 10 UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON THE KEYPAD. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE PUMP CASE WAS FOUND TO BE DAMAGED BETWEEN THE UPPER RIGHT CORNER OF THE DISPLAY LENS AND THE CASE SEAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED RELATED TO CYSTIC FIBROSIS. THE PUMP WAS REMOVED UPON ADMISSION TO THE HOSPITAL. WHILE IN HOSPITAL, HEMOGLOBIN A1C WAS DONE AND THE RESULT WAS 20.9, EQUIVALENT TO AVERAGE BLOOD GLUCOSE (BG) OF 553 MG/DL. THE REPORTER STATES A1C WAS 7.2 IN (B)(6) 2012. THE PATIENT STATES HER BLOOD GLUCOSE (BG) PRIOR TO ADMISSION HAD BEEN IN THE 100S MG/DL. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP AND IDENTIFIED ISSUES WITH INCORRECT DELIVERY DATES IN THE HISTORY. THE PUMP CURRENTLY HAD THE CORRECT DATE/TIME AND PATIENT STATES THE DATE AND TIME IS MAINTAINED WHEN SHE CHANGES BATTERY. PATIENT REPORTS NO ISSUES WITH KEYPAD AND BUTTONS RESPOND APPROPRIATELY. THE CLINICAL MANAGER VERIFIED PROGRAMMING OF I:C, ISF, BG TARGET, IOB. PATIENT USES NOVOLOG INSULIN, KEEPS CURRENT VIAL AT ROOM TEMPERATURE AND SPARE VIALS KEPT IN REFRIGERATOR. THE PUMP HAS NOT BEEN EXPOSED TO X-RAY OR MRI AND THERE ARE NO SITE/SET/CARTRIDGE ISSUES. THE PATIENT IS CURRENTLY OFF PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE PUMP HISTORY SHOWING INCORRECT DATES AND REPORTED DELIVERY RECORDS THAT THE PATIENT DENIED PROGRAMMING, AND TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY HAD A HEMOGLOBIN A1C EQUIVALENT TO A BG OVER 500 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69353 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening