BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2223279 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08096
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT AT AN UNSPECIFIED DATE AND TIME, MORE THAN A MONTH AGO, THE PATIENT ALLEGEDLY OBTAINED HIGHER READINGS AS COMPARED TO WHAT SHE GOT ON HER HEMOGLOBIN (HBA1C) TEST. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN, NOVOLOG AND LANTIS (UNKNOWN DOSES), AND THAT IN THE LAST MONTH, INCREASED HER INSULIN DOSAGES BY A "FEW UNITS" IN RESPONSE TO THE REPORTED ISSUE. APPROXIMATELY A MONTH AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING "DIZZY AND SWEATY" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING HOWEVER, IT WAS NOTED THAT THE SUBJECT METER WAS SET TO THE INCORRECT CODE NUMBER. THE CCA WAS ABLE TO WALK THE PATIENT THROUGH THE PROPER CODING PROCEDURES AS RECOMMENDED PER THE OWNER'S BOOKLET. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3003168

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening