BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2101129 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04333
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS DISPLAYING AN APPLY SAMPLE MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 1:15PM. IT IS NOT KNOWN HOW OFTEN THE PATIENT TESTS HIS BLOOD GLUCOSE; HOWEVER THE PATIENT MANAGES HIS DIABETES WITH METFORMIN (100MG, TWICE A DAY), NOVOLOG (14 UNITS AT BREAKFAST AND AT LUNCH, 12 UNITS AT NIGHT), AND LEVIMIR (20 UNIT IN THE MORNING AND 30 UNITS IN THE EVENING). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, A FEW MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF SWEATING AND CONFUSION. IT IS NOT KNOWN IF THE PATIENT ATTEMPTED TO TEST WITH A SECONDARY DEVICE AFTER THE ALLEGED ISSUE BEGAN; IT IS NOT KNOWN WHAT THE PATIENT'S LAST BLOOD GLUCOSE RESULT WAS PRIOR TO THE START OF THE ALLEGED ISSUE AND WHAT ACTION HE TOOK IN RESPONSE TO HIS PREVIOUS READING; IT IS NOT KNOWN IF THE PATIENT HAD MADE ANY CHANGES TO HIS DIABETES MANAGEMENT, ACTIVITY LEVEL, OR MEALS PRIOR TO WHEN THE ALLEGED ISSUE BEGAN; AND IT IS ALSO NOT KNOWN IF THE PATIENT ATTEMPTED TO ADMINISTER SELF-TREATMENT FOLLOWING THE ONSET OF HIS SYMPTOMS. AT AN UNKNOWN TIME LATER THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND ACCORDING TO THE CSR'S DOCUMENTATION AT 7PM, THE PATIENT WAS ADMINISTERED GLUCOSE TABLETS/GLUCOSE AS TREATMENT BY THE HEALTH CARE PROFESSIONAL (HCP) AND BETWEEN 9PM-10:15PM THE PATIENT OBTAINED READINGS OF "35, 47, 52, 68, A RESULT IN THE 80'S, AND 95MG/DL" WITH THE ER'S METER. IT IS NOT KNOWN IF THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM TO RECEIVE ANY ADDITIONAL MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT DID NOT HAVE THEIR TESTING SUPPLIES AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    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 Life Threatening| R