BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060318 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01076
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRAMINI METER HAD A PROCESSOR ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. AROUND 7 PM ON THREE DAYS PRIOR TO ORIGINAL DATE, THE PATIENT REPORTED THAT SHE WAS "SEEING PAST RESULTS" ON HER METER AND WAS NOT ABLE TO TEST HER BLOOD GLUCOSE. AS A RESULT OF THE REPORTED ISSUE WITH THE SUBJECT METER, THE PATIENT DID NOT TAKE ANY ACTIONS TOWARDS HER DIABETES TREATMENT. SHE ALSO REPORTED NOT HAVING ANY SYMPTOMS AFTER THE ALLEGED METER ISSUE. HOWEVER, AROUND 4 PM ON THE DAY PRIOR TO ORIGINAL DATE, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HER BLOOD GLUCOSE RESULTS WHEN TESTED ON THE HOSPITAL'S METER WERE: "378, 350 AND 344 MG/DL." AT THE HOSPITAL, THE PATIENT WAS REPORTEDLY TREATED WITH INSULIN (UNKNOWN TYPE AND DOSE). THE PATIENT TESTS HER BLOOD GLUCOSE ONCE A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: WHEN THE PATIENT TYPICALLY TESTS HER BLOOD GLUCOSE DURING THE DAY, HER DIABETES MANAGEMENT REGIMEN, HOW WAS SHE ADMITTED TO THE HOSPITAL, WHAT TYPE OF TREATMENT WAS ADMINISTERED AND LENGTH OF STAY AT THE HOSPITAL, WHAT HER LAST BLOOD GLUCOSE RESULT WAS ON THE REPORTED METER, AND WHEN THE RESULT WAS OBTAINED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT HER ACTIVITIES WERE BEFORE THE SYMPTOMS AND WHAT HER NORMAL BLOOD GLUCOSE READINGS ARE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. IT WAS DISCOVERED THAT THE PATIENT WAS INSERTING THE TEST STRIP INCORRECTLY (USE ERROR). THE ALLEGED ISSUE WAS RESOLVED WHEN A RETEST WAS PERFORMED WITH A NEW TEST STRIP. ALTHOUGH THE ALLEGED ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED FOR THE FOLLOWING REASON: THE PATIENT CLAIMED THAT SHE WAS NOT ABLE TO TEST ON THE SUBJECT METER AND THEN HOSPITALIZED AND TREATED WITH INSULIN AFTER THE REPORTED METER ISSUE. THE PATIENT'S PRODUCTS ARE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2757267

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R