BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1992285 · Received February 15, 2011

    Report

    Report Number
    2939301-2011-01387
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K062195. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2011 AT AN UNSPECIFIED TIME, THE PATIENT TESTED ON THEIR ULTRA 2 METER AND OBTAINED A 200 MG/DL AND TOOK INSULIN BASED ON THE METER READING . THE PATIENT SUDDENLY FELT TIRED, RETESTED ON THEIR METER AND OBTAINED A 26 MG/DL. THE PATIENT SELF-TREATED WITH GRAPE JUICE AND SYMPTOMS LASTED FOR 30 MINUTES. THE PATIENT TESTED ON THEIR LFS METER LATER ON THE SAME DAY AND OBTAINED A 264 MG/DL AT 7:00AM ON (B)(6) 2011 AND LESS THAN 30 MINUTES LATER, THE PATIENT TESTED ON SOMEONE ELSE'S ULTRA 2 METER AND OBTAINED A 136 MG/DL. ON (B)(6) 2011, THE PATIENT DEVELOPED SYMPTOMS OF BLURRED VISION AND WAS SHAKING. PRIOR TO THE SYMPTOMS THE PATIENT TESTED THEIR BLOOD GLUCOSE AND OBTAINED A 56 MG/DL AT 10:00AM. THE PATIENT'S SYMPTOMS CORRELATED WITH THEIR METER READING. THE PATIENT DENIED SEEKING ANY MEDICAL ATTENTION OR CONTACTING THEIR PHYSICIAN FOR ASSISTANCE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT AS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT THEY HAD TAKEN INSULIN BASED ON ALLEGED HIGH READING AND DEVELOPED SYMPTOMS AND HAD TO SELF-TREAT WITH JUICE FOR A BLOOD GLUCOSE OF 26 M/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3063272

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R