BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1023303 · Received April 1, 2008

    Report

    Report Number
    2939301-2008-00435
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA IS GIVING INACCURATE HIGH READINGS AND IS MISSING THE BARCODE AND SERIAL NUMBER ON THE LABEL. THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO OBTAIN MORE INFO ON MARCH 25, 2008. THE PT NOTICED THAT THE INACCURATE HIGH METER READINGS BEGAN ONE MONTH PRIOR TO ORIGINAL DATE. THE PT OBTAINED A BLOOD GLUCOSE READING OF "130 MG/DL" ON THE LFS METER AND "110 MG/DL" ON A HEALTHCARE PROFESSIONAL METER, PERFORMED MORE THAN 30 MINUTES OF EACH OTHER. TO COMPARE METER TO OTHER METER RESULTS, THE READINGS SHOULD BE TAKEN WITHIN 30 MINUTES AS PER LIFESCAN'S CRITERIA FOR ACCURACY COMPARISONS. WHEN MAS CONTACTED THE PT TO OBTAINED MORE INFO SURROUNDING THE ALLEGED SYMPTOMS, THE PT PROVIDED LIMITED INFO, AS HE DID NOT REMEMBER WHAT THAT DAY. AT AN UNSPECIFIED TIME AFTER THE REPORTED ISSUE BEGAN, THE PT INCREASED HIS SLIDING SCALE NOVOLOG INSULIN BY 3 UNITS BASED ON AN ALLEGEDLY INACCURATE HIGH READING (UNSPECIFIED) AND EXPERIENCED SYMPTOMS DESCRIBED AS "SWEATY AND LIGHTHEADED." THE PT CLAIMED THAT HE WENT TO THE HOSPITAL (UNSPECIFIED DATE AND TIME), TESTED AT "40 MG/DL", AND WAS TREATED WITH IV FLUID. IT IS NOT CLEAR WHAT READINGS THE PT OBTAINED PRIOR TO HOSPITAL VISIT. THE PT INDICATED THAT HE DOES NOT KNOW WHAT CAUSED THE SYMPTOMS BUT SPECULATES THAT HE DID NOT EAT ENOUGH ON THE DAY OF CONCERN. THE PT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY DID NOT CHANGE OR AFTER THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE UNIT OF MEASUREMENT WAS CORRECTLY SET TO MG/DL, THE TESTING TECHNIQUE WAS CORRECT, AND THE PUNCTURE AREA WAS CLEANED APPROPRIATELY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER HE TOOK INSULIN BASED ON A METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2778419

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R