BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3213267 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19097
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K002134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS SET TO THE INCORRECT UNIT OF MEASURE, MG/DL. ON (B)(6) 2013 THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT REPORTEDLY OBTAINED THE REPORTED METER FROM A FRIEND, AND WAS AWARE THE METER WAS LOCKED TO THE MG/DL UNIT OF MEASURE. ON (B)(6) 2013 AT 1:00 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 200 MG/DL (11.1 MMOL/L) ON THE REPORTED METER, WHICH SHE CORRECTLY INTERPRETED TO BE A READING OF ¿BETWEEN 11.0 AND 12.0 MMOL/L¿. THE PATIENT¿S USUAL READING AT THAT TIME OF DAY IS 7.0 MMOL/L. THE PATIENT TOOK THE ACTION OF TAKING AN INCREASED DOSE OF INSULIN, 1.0 UNITS MORE THAN HER USUAL DOSE; SHE WAS UNABLE TO PROVIDE THE SPECIFIC DOSE TAKEN. AT 3:15 AM, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, SWEATING AND WEAKNESS. THE PATIENT DID NOT TEST HER BLOOD GLUCOSE LEVEL WHILE SYMPTOMATIC. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING JUICE AND A BANANA, AND FELT BETTER AFTERWARDS. SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH NOVORAPID INSULIN 15 UNITS AND LEVEMIR INSULIN 36 UNITS PER DAY. ON (B)(6) 2013, THE DAY PRIOR TO THIS HYPOGLYCEMIC EVENT, THE PATIENT OBTAINED THE READING OF 375 MG/DL ON THE REPORTED METER. SHE WAS UNABLE TO PROVIDE DETAILS ABOUT THE MEALS AND INSULIN DOSES SHE HAD TAKEN THAT DAY. A REVIEW OF THE REPORTED METER¿S DEVICE HISTORY RECORD REVEALED THAT THIS METER WAS FACTORY-SET TO THE MMOL/L UOM. BASED ON THE METER¿S SERIAL NUMBER AND DATE OF MANUFACTURE, IT CAN BE SUGGESTED THAT THIS METER CAN BE SUBJECT TO EITHER CORRUPTION OF THE P1 PARAMETER OR BATTERY CONTACT, WHICH RESULT IN CHANGE OF UOM. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY EXPERIENCED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311927 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3359894

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R