BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2101220 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04351
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118. 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 (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRAEASY METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 8:00AM. THE PATIENT TESTED HIS BLOOD GLUCOSE AND OBTAINED A RESULT OF 300 MG/DL. LESS THAN 10 MINUTES LATER THE PATIENT OBTAINED A 216 MG/DL IN THE LAB. THE PATIENT TOOK A SET AMOUNT OF INSULIN AFTER OBTAINING THE RESULT OF 300 MG/DL. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AT THE TIME OF TESTING. AFTER TAKING THE INSULIN, THE PATIENT WENT TO SLEEP. HE WAS HOME ALONE AT THE TIME. HIS WIFE CAME BACK HOME AND CLAIMED THAT HE WAS "HYPOGLYCEMIC" AND WAS UNABLE TO PROVIDE THE EXACT SYMPTOMS SHE NOTICED HER HUSBAND HAD EXPERIENCED. SHE TREATED HIM WITH GRAPE WATER AND HE CLAIMED HE FELT BETTER APPROXIMATELY 15-30 MINUTES LATER. THE PATIENT WAS UNABLE TO PROVIDE HIS READINGS THE DAY BEFORE THE INCIDENT OR THE READINGS THE REST OF THE DAY. HE WAS ALSO UNABLE TO PROVIDE WHAT A "NORMAL" BLOOD GLUCOSE READING IS FOR HIM. THE TEST STRIP WAS IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TESTS TRIP WAS CORRECT. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED HIGH READING HE TOOK A SET AMOUNT OF INSULIN AND AT AN UNSPECIFIED TIME LATER HIS WIFE FOUND HIM "HYPOGLYCEMIC" AND TREATED HIM WITH GRAPE WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3055301

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R