BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 1981815 · Received February 8, 2011

    Report

    Report Number
    2939301-2011-01208
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 11:00AM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "86 MG/DL" WITH THE SUBJECT METER AND "43 MG/DL" ON ANOTHER METER (MEDTRONIC METER), PERFORMED AT AN UNKNOWN TIME OF EACH OTHER. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN PUMP. THE PATIENT REPORTEDLY DID NOT DEVELOP SYMPTOMS. THE PATIENT CLAIMED ½ AN HOUR AFTER THE ALLEGED ISSUE BEGAN, SHE ATE MORE FOOD AND/OR DRINK AND NOTIFIED EMERGENCY MEDICAL SERVICES (EMS). WHEN THE EMS ARRIVED, THE PATIENT STATED SHE WAS TESTED BY THE EMS METER AND OBTAINED A RESULT OF "43 MG/DL". ACCORDING TO THE PATIENT, SHE WAS IMMEDIATELY ADMINISTERED GLUCOSE TABLETS/GLUCOSE GEL. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AND THE PATIENT WAS ABLE TO PERFORM A CONTROL SOLUTION TEST. THE CONTROL SOLUTION RESULT WAS WITHIN THE SPECIFIED CONTROL SOLUTION RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER AND REPORTEDLY RECEIVED HCP INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3020078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention