BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3299203 · Received August 20, 2013

    Report

    Report Number
    2531779-2013-13368
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    July 21, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/25/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/09/20105 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BLACK BOX BEGINS ON 04/30/2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER, THE PATIENT¿S MOTHER, CONTACTED ANIMAS TO REPORT THE PATIENT HAD BEEN EXPERIENCING BLOOD GLUCOSE LEVELS RANGING FROM 34 MG/DL DURING THE NIGHT TO 500 MG/DL IN THE EVENINGS. THE PATIENT HAS EXPERIENCED SYMPTOMS OF MANIC ACTIVITY, AGITATION AND CONFUSION. THE REPORTER NOTED THE PATIENT WAS NOT VIEWING THE PUMP¿S DISPLAY WHILE GIVING HIMSELF A BOLUS DOSE, ONLY COUNTING THE BUTTON PRESSES. THIS INCORRECT PROCEDURE MAY HAVE CONTRIBUTED TO OVER-INFUSION OF INSULIN. TROUBLESHOOTING REVEALED THE PUMP WAS FUNCTIONING APPROPRIATELY AND ALL SETTINGS, PROGRAMMING AND DATE/TIME WERE CORRECT. THE PATIENT¿S TECHNIQUE WAS INCORRECT DURING BOLUSING OF INSULIN. THERE WAS NO EVIDENCE THE PUMP WAS NOT ACCURATELY AND CORRECTLY DELIVERING INSULIN. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE INJURY AFTER THIS EVENT OCCURRED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403121 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R