BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3240808 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11589
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON 08/14/2013 WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED IN THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP DID NOT APPEAR TO BE DELIVERING INSULIN WHEN THE INSULIN REMAINING REACHED 10 TO 20 UNITS REMAINING. THE REPORTER INDICATED THAT BLOOD GLUCOSE LEVELS WOULD ELEVATE INTO THE 300 TO 500 MG/DL RANGE WITH LETHARGY, DECREASE CONCENTRATION, AND HOT FLASHES. THE PUMP HISTORY WAS REVIEWED AND FOUND THAT THE BASAL RATES APPEARED CORRECT IN THE HISTORY AND THE REPORTER CONFIRMED THAT THE INSULIN REMAINING READING WAS DECREASING WITH THE BASAL INSULIN BUT BLOOD GLUCOSE LEVELS WERE ELEVATING BETWEEN 10 AND 20 UNITS INSULIN REMAINING. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH THE ALLEGATION THAT THE PUMP BASAL INSULIN DELIVERY WAS NOT FUNCTIONING APPROPRIATELY BETWEEN 10 AND 20 UNITS INSULIN REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341300 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening