BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2994037 · Received March 8, 2013

    Report

    Report Number
    2531779-2013-02496
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW REVEALS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED, 1 HOUR BASAL DELIVERY INTERRUPTION IS OBSERVED ON (B)(4) 2013 AS A RESULT OF LOSS OF PRIME. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REVEAL THE USER'S PROGRAMMED BASAL RATES TARGET. THE PUMP POWERS UP AND PAIRS WITH A TEST METER SUCCESSFULLY. THE UNIT WAS EXERCISED FOR 24 HOURS, NO ALARMS OCCURRED DURING TESTING. THE PUMP PASSED 29H FLOW ACCURACY TEST, AND IT WAS FOUND TO BE ABLE TO DELIVER TRUTHFULLY. PUMP¿S COVER WAS REMOVED, NO EVIDENCE OF MOISTURE INGRESS WAS FOUND. FORCE SENSOR CIRCUIT AND PCB WERE INSPECTED FOR INTERMITTENT CONDITION, NONE WAS FOUND. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A BLOOD GLUCOSE DOWN TO 2.7 MMOL/L WITH IRRITABILITY AND MODERATE TREMBLING; THE PATIENT REPORTED SELF TREATING THE BLOOD GLUCOSE WITH ORAL CARBOHYDRATE. THE PATIENT REPORTED FEELING THAT THE LOW BLOOD GLUCOSE MAY HAVE BEEN ASSOCIATED WITH A MASSAGE PRIOR TO THE EVENT. THE PUMP WAS REVIEWED AND CONFIRMED THAT ALL OF THE PUMP SETTINGS WERE PROGRAMMED APPROPRIATELY. THE PATIENT WAS ADVISED TO FOLLOW UP WITH A HEALTH CARE PROVIDER RELATED TO THE POSSIBLE NEED FOR SETTINGS ADJUSTMENTS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98763 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening