BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1081601 · Received July 25, 2008

    Report

    Report Number
    2939301-2008-01550
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 20, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT THE PATIENT'S ONE TOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE REPORTER REFUSED TO SPEAK/PROVIDE ANY FURTHER INFORMATION REGARDING THIS ISSUE/EVENT WHEN THE MEDICAL AFFAIRS SPECIALIST CONTACTED HER ON JULY 24, 2008. DURING THE INITIAL CALL, THE MOTHER HAD REPORTED THE FOLLOWING INFORMATION: THE PATIENT HAS TWO ONE TOUCH ULTRAMINI METER AND HAD REPORTEDLY OBTAINED RESULTS OF 191 MG/DL ON ONE METER AND 131 MG/DL ON ANOTHER (UNKNOWN WHICH RESULT WAS OBTAINED ON THE SUBJECT METER), PERFORMED WITHIN 10 MINUTES OF EACH OTHER. SHE ALSO MENTIONED THAT AFTER THE REPORTED ISSUE, SHE GAVE HER SON (PATIENT) SOME JUICE. HE THEN REPORTEDLY PASSED OUT AT AN UNKNOWN TIME. THERE IS NO FURTHER INFORMATION REGARDING SYMPTOMS, WHEN THE ISSUE FIRST OCCURRED, WHAT OTHER TREATMENT THE PATIENT HAD RECEIVED, OR ANY INFORMATION REGARDING THE PATIENT'S TESTING TECHNIQUE, OR TEST STRIP/METER INFORMATION. IT WAS VERIFIED DURING TROUBLESHOOTING THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT AFTER THE REPORTED ISSUE, THE PATIENT PASSED OUT. THE REASONS LEADING UP TO THE PATIENT ALLEGEDLY PASSING OUT, ARE UNKNOWN. IN ADDITION, THE ALLEGED RESULTS ARE ALSO OUTSIDE OF SPECIFICATION WHEN COMPARED TO THE OTHER METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2812164

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening