BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1897057 · Received November 11, 2010

    Report

    Report Number
    2939301-2010-09801
    Event Type
    Injury
    Date Received
    November 11, 2010
    Report Date
    October 15, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HIS ONETOUCH ULTRA METER WAS POWERING OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6) 2010 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY 3 WEEKS AGO PRIOR TO CONTACTING LFS AT AN UNSPECIFIED TIME. THE PATIENT INFORMED THE MSS THAT HE MANAGES HIS DIABETES WITH COMBINATIONS OF ORAL MEDICATION AND INSULIN. DESPITE THE ALLEGED ISSUE, THE PATIENT CLAIMED HE CONTINUED ADMINISTERING METFORMIN (UNKNOWN DOSE) BEFORE AND AFTER EACH MEAL AND 50 UNITS OF INSULIN (UNKNOWN TYPE) BEFORE EACH MEAL. THE PATIENT INDICATED PRIOR TO THE ALLEGED ISSUE, HE WAS FEELING LIGHTHEADED, SWEATY, SHAKY, AND NERVOUS; WHICH HE ASSOCIATED AS HIGH BLOOD SUGAR SYMPTOMS. THE PATIENT STATED SINCE HE WAS NOT ABLE TO TEST ON HIS METER AFTER THE ALLEGED ISSUE BEGAN, HIS SYMPTOMS BECAME WORSE. ON (B)(6) 2010, THE PATIENT CLAIMED HE TESTED ON HIS FRIEND'S METER (ACCUCHECK BRAND METER) AND OBTAINED A READING OF "560 MG/DL". THE PATIENT CLAIMED HE EXPERIENCED THE SAME SYMPTOMS BEFORE THE ALLEGED ISSUE BEGAN. ON THE SAME DAY OF THE ALLEGED READING OF "560 MG/DL", AT 12:15PM, THE PATIENT STATED HE WENT TO THE URGENT CARE/CLINIC AND WAS TESTED BY THE DOCTOR/CLINIC METER. THE PATIENT REPORTED OBTAINING A READING OF OVER "560 MG/DL" FROM THE DOCTOR/CLINIC METER AND WAS IMMEDIATELY ADMINISTERED INSULIN (UNKNOWN TYPE AND DOSE) AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE BATTERY NEEDED REPLACEMENT; HOWEVER THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA PRIOR TO THE ALLEGED ISSUE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST FOR THREE WEEKS DUE TO THE REPORTED ISSUE AND DURING THIS TIME HIS SYMPTOMS BECAME WORSE AND THEN HE RECEIVED MEDICAL INTERVENTION BY A HEALTH CARE PROFESSIONAL (HCP).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R