BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2994097 · Received March 8, 2013

    Report

    Report Number
    2531779-2013-02497
    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
    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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS A PRIME OCCURRING FOLLOWING A LOSS OF PRIME DUE TO AN AUTO ALARM OFF. BLACK BOX SHOWS TIME AND DATE RESETTING TO DEFAULT FOLLOWING A POWER ON RESET. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A PRIME WAS PERFORMED AND WAS ACCURATELY RECORDED IN PUMP HISTORY. AN AUTO OFF ALARM WAS DUPLICATED DURING TESTING; PUMP GIVES APPROPRIATE "AUTO OFF NO DELIVERY" AUDIBLE AND VISUAL ALARM. WHEN THE AUTO OFF ALARM WAS CONFIRMED PUMP GAVE AUDIBLE AND VISUAL "PUMP NOT PRIMED" WARNING. THERE WAS NO DEFECT FOUND ASSOCIATED WITH THE ORIGINAL COMPLAINT. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING UNEXPLAINED LOW BLOOD GLUCOSE LEVELS WITH DIFFICULTY BRINGING BLOOD GLUCOSE LEVELS UP TO NORMAL RANGE. THE PATIENT REPORTED HAVING BLOOD GLUCOSE LEVELS AS LOW AS 3.1MMOL/L WITH TIREDNESS AND VOMITING. THE PATIENT REPORTEDLY TREATED THE LOW BLOOD GLUCOSE WITH ORAL CARBOHYDRATE AND DISCONNECTED FROM THE PUMP. THE PATIENT CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT. THE PATIENT CONFIRMED NO PRIMES OR FILL CANNULA STEPS WERE PERFORMED DURING THE LOW BLOOD GLUCOSE EVENT. A REVIEW OF THE PUMP PRIME HISTORY INDICATED THAT THE PATIENT HAD A PRIME OF 7.1 UNITS AT 6:40 PM. THE PATIENT REPORTED NO ACCIDENTAL PRIMES OR ALARMS REQUIRING PRIMING OCCURRING DURING THE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA RELATED TO AN UNPROGRAMMED PRIME IN THE PUMP HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100148 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening