BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222982 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10487
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY CONFIRMED THE REPORTED PRIME VOLUMES. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THERE WAS NO EVIDENCE OF PUMP NOT PRIMED OR NO CARTRIDGE DETECTED WARNINGS IN THE HISTORY. DURING TESTING, THE PUMP PERFORMED THE REWIND, LOAD, AND PRIME STEPS SUCCESSFULLY WITH NO WARNINGS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. A CARTRIDGE WITH 100 UNITS WAS CORRECTLY LOADED INTO THE PUMP. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE INTERNAL CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    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 THAT ON (B)(6) 2013 THE PATIENT EXPERIENCED THE SYMPTOMS OF VOMITING AND TESTED POSITIVE FOR KETONES, AND HIS BLOOD GLUCOSE LEVEL WAS 680 MG/DL. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA, AND HE WAS TREATED INTRAVENOUSLY WITH INSULIN. TROUBLESHOOTING REVEALED ALL PUMP SETTINGS AND PROGRAMMING AND DATE/TIME WERE CORRECT, AND ALL TOTAL BASAL/BOLUS DOSES GIVEN CORRECTLY MATCHED THOSE PROGRAMMED. A REVIEW OF THE PUMP PRIME HISTORY REVEALED THE PATIENT¿S TECHNIQUE WAS INCORRECT BY NOT COMPLETING THE FILL CANNULA STEP AFTER REPLACING THE INFUSION SET/SITE. THERE WAS NO EVIDENCE THE PUMP WAS NOT FUNCTIONING APPROPRIATELY IN ACCURATELY AND CORRECTLY DELIVERING INSULIN AS PROGRAMMED. THE PATIENT¿S TECHNIQUE WAS INCORRECT BY NOT FILLING THE INFUSION SET CANNULA, WHICH MAY HAVE CONTRIBUTED TO UNDER-INFUSION OF INSULIN. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AND WAS ADMITTED TO THE ICU WITH DKA WHILE USING THE REPORTED PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323462 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L