BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2182924 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06560
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 9, 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN EXPIRATION ISSUE WITH HER ONE TOUCH ULTRA2 METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN APPROXIMATELY ON (B)(6) 2011. IT IS UNKNOWN HOW SHE MANAGES HER DIABETES, OR IF SHE TOOK ANY ACTION DUE TO THE ALLEGED PRODUCT ISSUE. AT AN UNSPECIFIED DAY AND TIME, AFTER THE ALLEGED ISSUE BEGAN, SHE REPORTED FEELING LIGHTHEADED, HAD BLURRY VISION AND A HEADACHE. THE PATIENT CLAIMED THAT SHE BECAME SYMPTOMATIC BECAUSE SHE REFUSED TO USE THE NEWLY RECEIVED METER KIT. PER THE DOCUMENTATION, THE PATIENT ASSUMED THE EXPIRATION DATE OF (B)(6) 2012 ON THE BOX, REFERRED TO THE METER'S EXPIRY DATE. IT IS UNCLEAR WHY THE PATIENT WOULD NOT USE THE METER OR HOW SHE MISINTERPRETED AN EXPIRATION OF (B)(6) 2012. SHE DENIED RECEIVING ANY TREATMENT DUE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH THE CCA, THE PATIENT WAS EDUCATED ON THE SIGNIFICANCE OF THE EXPIRATION DATE PRINTED OUTSIDE ON THE KIT BOX AND THE ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE EXPIRATION DATE ON THE BOX AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3085495

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening