BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2843042 · Received November 21, 2012

    Report

    Report Number
    3008382007-2012-06590
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 16, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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) 2012 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIOPRO METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2012, THE TECHNICAL SUPPORT REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON (B)(6) 2012 AT 5:42 PM, AFTER EATING CANDY, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 272 MG/DL ON THE REPORTED METER. BASED ON THIS READING, THE PATIENT TOOK 4.0 UNITS NOVORAPID INSULIN. TROUBLESHOOTING REVEALED THE PATIENT HAD NOT WASHED HIS HANDS AFTER EATING THE CANDY PRIOR TO PERFORMING THIS BLOOD GLUCOSE TEST. AFTER TAKING THIS INSULIN DOSE, THE PATIENT ATE ONE PIECE OF TOAST. THIS WAS NOT A NORMAL TIME OF DAY FOR THE PATIENT TO TEST HIS BLOOD GLUCOSE LEVEL AND TAKE INSULIN. AT 9:28 PM THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING, CONFUSION AND DISORIENTATION. WHILE SYMPTOMATIC, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL TO BE 70 MG/DL ON THE REPORTED METER, AND 31 MG/DL USING ANOTHER ONE TOUCH ULTRAEASY METER. THE PATIENT WAS TREATED WITH DEXTROSE AND SODA, AND FELT BETTER AFTERWARDS. BETWEEN 9:55PM AND 10:34 PM THE PATIENT OBTAINED THE FOLLOWING BLOOD GLUCOSE READINGS COMPARING THE REPORTED METER TO HIS OTULTRAEASY METER: OT VERIO PRO METER / OT ULTRAEASY METER; 341 MG/DL / 142 MG/DL, 429 MG/DL / 161 MG/DL, 150 MG/DL / 100 MG/DL, 262 MG/DL / 245 MG/DL, 290 MG/DL / 257 MG/DL. DURING THE TROUBLESHOOTING TELEPHONE CALL, A QUALITY CONTROL SOLUTION TEST WAS PERFORMED, WITH PASSING RESULTS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT'S TECHNIQUE WAS INCORRECT BY NOT PROPERLY CLEANSING THE FINGERSTICK SITE BEFORE PERFORMING THE FINGERSTICK TO PERFORM THE BLOOD GLUCOSE TEST. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INSULIN DOSE BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH GLUCOSE AND FOOD, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3336453

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R