BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAMINI

    MDR report key: 915745 · Received September 18, 2007

    Report

    Report Number
    2939301-2007-00996
    Event Type
    Injury
    Date Received
    September 18, 2007
    Date of Event
    August 26, 2007
    Report Date
    August 27, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    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

    ON AUG 27, 2007 AT 12:30 PM, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING, THE ONE TOUCH ULTRAMINI IS GIVING INACCURATE HIGH READINGS COMPARED TO NORMAL READING/FEELING. THE COMPLAINT IS CLASSIFIED BASED ON THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE (CCA). THE REPORTED ISSUE BEGAN IN 2007, AT 1:43PM. THE PATIENT REPORTEDLY OBTAINED READING OF "140, 136 AND 146 MG/DL." AFTER THE REPORTED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "TIRED AND SHAKY". THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AND DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. DURING TROUBLESHOOTING, THE PATIENT VERIFIED THAT HE USING THE CORRECT TESTING TECHNIQUE, THE PUNCTURE AREA WAS CLEANED CORRECTLY, THE UNIT OF MEASUREMENT SET THE CORRECTLY TO MG/DL, AND THE METER'S MEMORY MATCHED WITH THE REPORTED RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2652261

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening