BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1560465 · Received December 11, 2009

    Report

    Report Number
    2939301-2009-07573
    Event Type
    Injury
    Date Received
    December 11, 2009
    Report Date
    November 23, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/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

    THE LAY USER / PATIENT CONTACTED LFS ON NOVEMBER 23, 2009, ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON DECEMBER 11, 2009 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT A WEEK AND HALF PRIOR TO CONTACTING LFS HE HAD OBTAINED READINGS ANYWHERE FROM 243, 434, 302, 274, 345, 254, 258, 355, 205, 398 THROUGHOUT THE WEEK. HE CONFIRMED THAT THE RESULTS WERE NEVER DONE BACK TO BACK. ON AN UNSPECIFIED DATE AND TIME, 2-3 TIMES DURING THAT WEEK AND HALF, HE EXHIBITED SYMPTOMS OF FEELING SWEATY, CONFUSED AND FELT LIKE PASSING OUT, 2 HOURS AFTER TAKING AN INCREASE DOSAGE OF INSULIN BASED ON THE METER RESULT. PATIENT DOES NOT RECALL THE TIME AND DATE OF THE EVENTS. HE MENTIONED THAT HE WOULD TEST WHEN HE EXHIBITED THE SYMPTOMS AND THE METER WOULD DISPLAY A LOW READING AND HE WOULD SELF-TREAT WITH FOOD AND FEEL BETTER. HE NEVER CONTACTED HIS PHYSICIAN OR SOUGHT ANY FURTHER MEDICAL ATTENTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ELEVATED READING, HE TOOK AN INCREASE DOSAGE OF INSULIN AND ENDED UP DEVELOPING SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND HAD TO SELF-TREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2931547

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R