BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 1972908 · Received January 28, 2011

    Report

    Report Number
    2939301-2011-00981
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH SELECT METER READ INACCURATELY COMPARED TO HIS EXPECTED RESULT. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HIS BLOOD GLUCOSE 2X A DAY. THE PATIENT MANAGES HIS DIABETES WITH ACTOS PILLS AND GLIPIZIDE PILLS (AMOUNTS NOT SPECIFIED).THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2011. THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION. THAT SAME EVENING, THE REPORTER CLAIMED THE PATIENT WAS SHAKY AND "NOT MOVING RIGHT." THE REPORTER STATED EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE REPORTER WAS NOT ABLE TO CONFIRM RESULTS OBTAINED FROM THE EMS METER BUT CLAIMED THE PATIENT'S BLOOD GLUCOSE WAS READING "VERY HIGH." THE PATIENT WAS ADMINISTERED INSULIN (TYPE/ AMOUNT NOT SPECIFIED) AS TREATMENT. THE REPORTER STATED THE PATIENT WAS TAKEN TO THE HOSPITAL AND WAS RELEASED AFTER 7 DAYS. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE CCA WAS UNABLE TO WALK THE REPORTER THROUGH A CONTROL SOLUTION TEST TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3051591

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R