BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1063376 · Received June 19, 2008

    Report

    Report Number
    2939301-2008-01126
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON MAY 28, 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PT TO OBTAIN ADD'L INFO. ON THE DAY BEFORE, THE PT REPORTED THAT RIGHT AFTER EXERCISING, A READING OF "109 MG/DL" WAS OBTAINED ON A BACKUP METER (OT ULTRAMINI). WHEN THE PT CAME HOME, A RETEST WAS PERFORMED ON THE SUBJECT METER (ULTRA2) AND A READING OF "288 MG/DL" WAS OBTAINED AT 8 PM. LATER ON AT 8:19 PM, THE PT RETESTED ON THE SUBJECT METER AND A READING OF "206 MG/DL" WAS REPORTEDLY OBTAINED. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/OR <=30 MG/DL FOR LFS PRECISION CRITERIA. THE PT ALLEGEDLY FELT THE READINGS WERE INACCURATELY HIGH, SO SHE RETESTED HER BLOOD GLUCOSE ON A BACK UP METER AND A "47 MG/DL" WAS OBTAINED. HOWEVER, SHE CLAIMED THAT SHE TREATED HERSELF BASED ON THE "HIGHER" READINGS THAT WERE OBTAINED ON THE SUBJECT METER. SHE REPORTEDLY TOOK AN EXTRA 10 UNITS OF NOVOLOG AND DRANK WATER (THE PT INDICATED THAT DRINKING WATER USUALLY BRINGS DOWN HER BLOOD GLUCOSE). ABOUT THIRTY MINS AFTER THE SELF-TREATMENT, SHE REPORTEDLY FELT SYMPTOMS OF "CONFUSED, BLURRY VISION AND SHAKY" THAT LASTED TWENTY-FIVE MINS UNTIL SHE TREATED HERSELF WITH JUICE AND FELT BETTER. THE PT INDICATED THAT NORMALLY HER BLOOD SUGAR IN THE MORNING WOULD BE "80-89 MG/DL" AND HIGHEST BLOOD SUGAR IS "120 MG/DL" BEFORE MEALS AND "140 MG/DL" AFTER MEALS. THE PT TESTS HER BLOOD GLUCOSE FIVE TO SIX TIMES A DAY AND MANAGES HER DIABETES WITH NOVOLOG, LANTUS AND GLUCOPHAGE (UNSPECIFIED DOSE). AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUE AND THAT THE PUNCTURE AREA WAS CLEANED PROPERLY. THE METER'S UNIT OF MEASURE WAS SET CORRECTLY TO MG/DL. HOWEVER, IT WAS ALSO VERIFIED THAT THE RESULT FROM THE MEMORY DID NOT MATCH AND THE CONDITION OF THE TEST STRIP WAS DAMAGED. THE PT'S PRODS ARE BEING REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2731266

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R