BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2042670 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02853
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS DISPLAYING THE "ERROR 1" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT SHE DID NOT WANT TO SPECIFY THE TYPE AND DOSAGE OF DIABETES MEDICATIONS SHE WAS TAKING. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011 AT AN UNKNOWN TIME. DESPITE THE ALLEGED ISSUE, THE PATIENT CORRECTED AND CONFIRMED SHE CONTINUED TAKING HER DOSE OF DIABETES MEDICATIONS. THE PATIENT CONFIRMED SHE HAD SYMPTOMS OF BLURRY VISION AND FELT LIGHTHEADED 2-3 DAYS AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO HER SYMPTOMS, THE PATIENT STATED SHE ATE SOME PROCESS CHICKEN NUGGETS AND THEN RESTED WHILE SHE WAS AT SCHOOL. LATER THAT EVENING, THE PATIENT STATED SHE FELT BETTER, SO SHE WENT TO PURCHASE A NEW METER, SINCE SHE DID NOT HAVE ANOTHER METER TO USE AT THE TIME THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R