BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1821228 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07405
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 10, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED DURING THE FOLLOW-UP CALL IN ADDITION TO THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2010, WHEN HE BEGAN TO USE THE SUBJECT METER FOR THE FIRST TIME. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED HE OBTAINED BLOOD GLUCOSE READINGS OF "221 MG/DL" WITH THE SUBJECT METER, "135 MG/DL" ON HIS SPOUSE'S METER, AND "137 MG/DL" ON HIS OTHER METER (ACUCHECK), PERFORMED LESS THAN 30 MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/OR <= 30 MG/DL. THE PATIENT STATED THAT THE HE TESTS HIS BLOOD GLUCOSE 2X/DAY AND MANAGES HIS DIABETES BY TAKING A SET DOSE OF LANTUS INSULIN AT NIGHT (IF BLOOD GLUCOSE IS OVER 175 MG/DL)AND ORAL MEDICATIONS (METFORMIN, GLIPIZIDE AND ACTOS) DURING THE DAY. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE RESULTS HE OBTAINED WITH THE SUBJECT METER. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF FEELING SHAKY, SLEEPY, WEAK AND "WEIRD" ON THE EVENING OF (B)(6) 2010. THE PATIENT CLAIMED THAT AT THE ONSET OF SYMPTOMS HE TESTED WITH HIS WIFE'S METER AND OBTAINED A RESULT OF "55 MG/DL." THE PATIENT STATED THAT HE FELT BETTER AFTER EATING SOMETHING. AT THE TIME OF TROUBLESHOOTING, THE CCA DISCOVERED THAT THE SUBJECT METER WAS SET TO THE INCORRECT CODE NUMBER. THE CCA EDUCATED THE PATIENT ON CONFIRMING THE CODE ON THE METER PRIOR TO TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3022394

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R