BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1802031 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06675
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    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 MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE HIGH READING OF "270 MG/" COMPARED TO NORMAL READING/FEELINGS. THE PATIENT'S DIABETES IS MANAGED WITH INSULIN- NO ADJUSTMENT. ON (B)(6) 2010 AT 8:30 AM, THE PATIENT REPORTEDLY OBTAINED THE ALLEGED INACCURATE HIGH READING. THE PATIENT DID NOT TAKE ANY ACTION AT THE TIME OF CONCERN. REPORTEDLY 5 MINUTES LATER, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "SHAKES, SWEATS, VERY NERVOUS, AND WEAK." AT 9 AM, THE PATIENT ADMINISTERED SELF TREATMENT WITH ORANGE JUICE, PEANUT BUTTER, AND GLUCOSE TABLETS. NO OTHER DEVICES WERE USED AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THERE WAS NO CONTROL SOLUTION TO PERFORM A QUALITY TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AND RECEIVED MEDICAL INTERVENTION ACCORDINGLY 5 MINUTES AFTER THE PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3006533

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R