BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 1982890 · Received February 9, 2011

    Report

    Report Number
    2939301-2011-01245
    Event Type
    Injury
    Date Received
    February 9, 2011
    Report Date
    January 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY LOW COMPARED TO HER FEELING/ NORMAL RESULT(S). 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 AN UNKNOWN DATE/TIME IN SEPTEMBER (YEAR NOT SPECIFIED). ON AN UNKNOWN DATE/TIME THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "107, 117, AND 67MG/DL" WITH THE SUBJECT METER. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH 15MG OF ACTOS TWICE A DAY, 4MG OF GLYBURIDE TWICE A DAY, AND 20 UNITS OF LANTUS IN THE EVENING; HOWEVER, PATIENT'S TESTING FREQUENCY IS NOT SPECIFIED. PER CSR'S NOTES, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED INACCURATE LOW RESULTS. FOLLOWING THE REPORTED ISSUE, IT IS NOT KNOWN IF THE PATIENT CONTINUED TO TEST HER BLOOD GLUCOSE WITH THE SUBJECT METER OR IF THE PATIENT TESTED WITH A SECONDARY DEVICE. IT IS ALSO NOT KNOWN IF THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE REPORTED ISSUE. THE PATIENT ALSO CLAIMED BEFORE (B)(6) 2010, SHE WAS HOSPITALIZED FOR FOUR DAYS. DURING HER ALLEGED HOSPITALIZATION THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS BETWEEN "250'S AND 500'S" WITH THE HOSPITAL METER. THE PATIENT ALLEGEDLY WAS ADMINISTERED INSULIN AND DIFFERENT MEDICATIONS (TYPE/DOSES UNKNOWN). PRIOR TO PATIENT'S HOSPITAL VISIT, IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE RESULT WAS WITH THE SUBJECT METER, IT IS NOT KNOWN WHAT PROMPT THE PATIENT TO GO TO THE HOSPITAL, AND IT IS ALSO NOT KNOWN IF THE PATIENT HAS ADDITIONAL HEALTH CONDITIONS. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT (MG/DL). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE LOW READINGS ON THE SUBJECT METER; HOWEVER, THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPERGLYCEMIA AND WAS ALLEGEDLY HOSPITALIZED 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. 3058188

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R