BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3173785 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08374
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/08/2013 WITH THE FOLLOWING FINDINGS: A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THERE WAS NO DEFECT FOUND. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT HAD FLUCTUATING BLOOD GLUCOSE LEVELS FOR SEVERAL DAYS. THE REPORTER STATED THAT THE PATIENT BLOOD GLUCOSE LEVELS WERE GOING AS LOW AS 2.8 MMOL/L WITH NO SYMPTOMS UP TO 24 MMOL/L. THE REPORTER INDICATED THAT THE PATIENT TREATED THE LOW BLOOD GLUCOSE WITH ORAL CARBOHYDRATE AND TREATED THE ELEVATED BLOOD GLUCOSE LEVELS WITH BOLUS FROM THE PUMP. THE REPORTER INDICATED THAT THERE MAY BE SOME NEED FOR PUMP SETTINGS ADJUSTMENTS BUT THE REPORTER WANTED TO INSURE THAT THE PUMP WAS FUNCTIONING CORRECTLY. THE REPORTER INDICATED THAT THE PUMP WAS UNAVAILABLE FOR REVIEW AT THE TIME OF THE EVENT. THE REPORTED BLOOD GLUCOSE LEVEL DO NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BECAUSE THE REPORTER QUESTIONED IF THE PUMP¿S INSULIN DELIVERY WAS FUNCTIONING IN RELATION TO THE PATIENT¿S BLOOD GLUCOSE FLUCTUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274094 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR