BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2192865 · Received August 5, 2011

    Report

    Report Number
    2939301-2011-06911
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. A 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH SELECT METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED PRODUCT ISSUE OCCURRED ON (B)(6) 2011 AT AROUND 5:10AM AND IMMEDIATELY AFTER, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "NUMB LIPS AND CLAMMY FEELING". THE CCA WAS INFORMED BY THE PATIENT THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE. THE PATIENT STATED TAKING MORE FOOD/DRINK IN RESPONSE TO BOTH THE ALLEGED ISSUE AND THE SYMPTOMS, RIGHT AFTER THE REPORTED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT TYPE OF TEST STRIPS WAS BEING USED AND THERE WAS NO EVIDENCE OF MISUSE. THE CCA ALSO NOTED THAT THE BATTERY DID NOT REQUIRE REPLACEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED PRODUCT ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3042741

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening