BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3244031 · Received July 24, 2013

    Report

    Report Number
    3008382007-2013-20818
    Event Type
    Injury
    Date Received
    July 24, 2013
    Report Date
    July 3, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING A ONE TOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE STARTED IN ¿(B)(6) 2013¿. AT AN UNSPECIFIED DATE/TIME, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿290 MG/DL¿ ON THE SUBJECT METER AND ¿247 MG/DL¿ ON ANOTHER DEVICE (ACCUCHECK). BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% OR <=20MG/DL WHEN OBTAINED WITHIN 20 MINUTES. THE REPORTER STATED THE PATIENT MANAGES HIS DIABETES WITH SELF ADJUSTING INSULIN (UNKNOWN TYPE AND DOSAGE). THE REPORTER MENTIONED THAT THE PATIENT HAD SOMETHING MORE TO EAT OR DRINK IN RESPONSE TO THE ALLEGED INACCURATE READING OBTAINED WITH THE SUBJECT METER."SOON AFTER" THE ALLEGED ISSUE OCCURRED, THE REPORTER STATED THE PATIENT DEVELOPED SYMPTOMS OF ¿WEAK, BLURRY VISION¿. THE REPORTER MENTIONED THAT THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND REQUIRED SELF TREATMENT TO PREVENT ADDITIONAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346459 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3439669

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R