BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 914636 · Received September 14, 2007

    Report

    Report Number
    2939301-2007-00950
    Event Type
    Injury
    Date Received
    September 14, 2007
    Date of Event
    August 15, 2007
    Report Date
    August 16, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2007, THE LAY PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA SMART METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S DOCUMENTATION. THE PATIENT USES INSULIN; HOWEVER, HER SPECIFIC DIABETES TREATMENT REGIMEN WAS NOT PROVIDED. THE PATIENT SAID THE REPORTED METER STOPPED WORKING ON THE MORNING OF TWO DAYS EARLIER. THE PATIENT WAS TAKEN TO THE ER ON AUGUST 15, 2007 WHEN SHE WAS NOT FEELING WELL; SHE WAS TIRED, URINATING A LOT, HAVING STOMACH PAINS, NAUSEA, AND A YEAST INFECTION. A LABORATORY RESULT OF 346 MG/DL WAS OBTAINED AT THE ER. THE PATIENT WAS TREATED WITH HUMALOG 75/25 INSULIN, DOSE UNKNOWN. THE CCA NOTED THAT THE PATIENT CHANGED THE METER BATTERY PER THE OWNER'S MANUAL. THE METER DID NOT TURN ON WHEN THE POWER BUTTON WAS PRESSED OR WHEN A TEST STRIP WAS INSERTED INTO THE TEST STRIP PORT. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT ALLEGES SHE WAS UNABLE TO OBTAIN A READING ON THE LFS PRODUCT AND LATER EXPERIENCED SYMPTOMS AND A HYPERGLYCEMIC LABORATORY BLOOD GLUCOSE READING. SHE CLAIMS SHE WAS TREATED WITH INSULIN IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2722832

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R