BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2220886 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07929
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 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. THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE EXPERIENCED A 'PACKAGING ISSUE' WITH HER ONETOUCH ULTRA2 SYSTEM KIT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ON (B)(6) 2011 AT 3PM, THE LANCETS IN HER SYSTEM KIT WERE ALLEGEDLY MISSING. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE. FIFTEEN MINUTES AFTER THE ALLEGED PRODUCT ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF 'SWEATING AND SHAKING' AND SHORTLY AFTER DECREASED HER ORAL MEDICATION (UNKNOWN TYPE) TO 15MG IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. DURING TROUBLESHOOTING, THE CCA WAS ABLE TO ASSIST THE PATIENT IN LOCATING THE LANCETS WITHIN THE SYSTEM KIT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT AFTER THE ALLEGED PRODUCT ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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. 3170566

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening