BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1955395 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00316
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 15, 2010
    Report Date
    December 27, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6), 2011 AND VERIFIED/OBTAINED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS 3 TIMES DAILY AND ORALLY TAKES 2.5MG OF GLIPIZIDE PILLS 3 TIMES DAILY WITH DIET/EXERCISE THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 2:30PM. DUE TO THE ALLEGED ISSUE, THE PATIENT STATED SHE ATE LESS FOOD AND/OR DRINK. THE PATIENT CLAIMED 10 MINUTES AFTER THE ALLEGED ISSUE BEGAN, SHE BECAME SWEATY; WHICH SHE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO THE SYMPTOM, SHE CONTACTED HER HEALTH CARE PROVIDER (HCP) BY PHONE FOR ADVICE. ACCORDING TO THE PATIENT, HER HCP ADVISED HER TO DRINK A GLASS OF ORANGE JUICE AND SHE MENTIONED THAT SHE TOOK IT UPON HERSELF TO EAT A PIECE OF CANDY. THE PATIENT CLAIMED 10 MINUTES AFTER THE TREATMENT, SHE FELT BETTER. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE , THERE WAS NO MISUSED OF THE METER, THE CORRECT TEST STRIPS WERE USED, AND DID NOT REQUIRE A NEW BATTERY REPLACEMENT. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE SUBJECT METER NOT POWERING ON AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2959972

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R