BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 3011236 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05579
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT AN UNSPECIFIED LIFESCAN METER WAS GIVING INACCURATE READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 AT 5:00 PM THE PATIENT OBTAINED A BLOOD GLUCOSE READING ON THE REPORTED METER WHICH SHE CLAIMED WAS INACCURATE. THE REPORTER REFUSED TO PROVIDE THE SPECIFIC RESULT. AFTERWARDS, THE PATIENT TOOK HER USUAL DOSE OF BOTH RAPID-ACTING AND LONG-ACTING INSULIN. IMMEDIATELY AFTERWARDS, THE PATIENT PASSED OUT. EMERGENCY SERVICES WERE CONTACTED. PARAMEDICS ARRIVED AND AT 4:15 PM TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 43 MG/DL. THE PATIENT WAS TREATED WITH FOOD AND/OR A DRINK. THE PATIENT'S TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A REPORTED METER READING, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113480 UNKNOWN METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3318082

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R