BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2035630 · Received March 31, 2011

    Report

    Report Number
    2939301-2011-02733
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 K053529.

    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 ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER EXPECTED RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE REPORTER STATED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "152, 139, 182 AND 167 MG/DL." IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR WHAT ACTION SHE TOOK AT THE TIME OF THE ALLEGED ISSUE. AT AN UNSPECIFIED DATE/TIME AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT DISORIENTED AND PASSED OUT. THE REPORTER STATED THE PATIENT WAS ADMINISTERED A GLUCAGON INJECTION AS TREATMENT AND WAS ADMITTED INTO THE HOSPITAL. THE REPORTER COULD NOT SPECIFY RESULTS OBTAINED FROM THE EMERGENCY ROOM (ER)/ HOSPITAL METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION 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 SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3085228

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R