BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2222778 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08077
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL # OF METER (B)(4). 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. THE PRODUCTS WERE REPLACED AND REQUESTED BACK. THE METER WAS RETURNED AND THE METER PASSED TESTING. THE TEST STRIPS HAVE NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH ULTRA MINI METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT ON (B)(6) 2011 AT AN UNSPECIFIED TIME SHE HAD TESTED HER BLOOD GLUCOSE AND OBTAINED A READING OF 180 MG/DL. SHE DID NOT TAKE ANY ACTION AND SHORTLY AFTER SHE STARTED HAVE CONVULSIONS AND NEARLY PASSED OUT. SHE WAS TREATED AT HOME BY A NON-HCP WITH JUICE AND SUGAR. HER BLOOD GLUCOSE WAS NOT TESTED AT THE TIME OF SYMPTOMS. SHE WAS TAKEN TO THE ER AND WAS TREATED WITH IV GLUCOSE AND SHE DOES NOT RECALL WHAT HER INITIAL READING WAS IN THE HOSPITAL; HOWEVER PRIOR TO LEAVING THE ER HER BLOOD GLUCOSE WAS 120 MG/DL. HER DIABETES REGIMEN WAS NOT CHANGED DUE TO THE ALLEGED ISSUE. THE PATIENT WAS IN THE ER FOR APPROXIMATELY 4 HOURS. SHE CLAIMED THE DIAGNOSIS WAS "HYPOGLYCEMIA". THE TEST STRIPS WERE REPLACED AND WAS IN GOOD CONDITION. THE TEST STRIPS WERE NOT EXPIRED AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHORTLY AFTER OBTAINING THE ALLEGED HIGH READING OF 180 MG/DL, SHE DEVELOPED SYMPTOMS AND HAD TO BE TREATED WITH JUICE AND WAS TAKEN TO THE ER WHERE SHE WAS TREATED WITH IV GLUCOSE FOR "HYPOGLYCEMIA".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L| R