BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2022587 · Received March 17, 2011

    Report

    Report Number
    2939301-2011-02316
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    March 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 510K # K062195.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2012) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED LIFESCAN (B)(6) ALLEGING THAT THE PATIENT OBTAINED INACCURATELY LOW READINGS ON THE ONETOUCH ULTRA SYSTEM KITS PRIOR TO BEING HOSPITALIZE FOR HYPERGLYCEMIA. THE PATIENT'S DIABETES IS NOT MANAGED WITH DIABETES MEDICATION PRIOR TO THE HOSPITALIZATION. DURING THE MONTH OF (B)(6) 2011, THE PATIENT REPORTEDLY USED TWO ONETOUCH ULTRA METERS TO MANAGE HIS DIABETES. REPORTEDLY, HIS BLOOD GLUCOSE READINGS RANGED FROM "75 MG/DL TO 111 MG/DL" DURING THE MONTH IS QUESTION. HOWEVER, ON (B)(6) 2011 WHILE THE PATIENT'S BLOOD GLUCOSE READING "NORMAL" ON THE ALLEGED ONETOUCH METERS, THE PATIENT CLAIMED HE DID NOT FEEL WELL AND WAS UNABLE TO WALK. ON (B)(6) 2011, THE PATIENT WENT TO THE HOSPITAL WHERE HIS BLOOD GLUCOSE WAS TESTED AT "400 MG/DL" DURING A FASTING STATE. HE WAS IMMEDIATELY HOSPITALIZED AND RECEIVED INSULIN TREATMENT. THE PATIENT CLAIMED THAT HIS MEDICAL CONDITION INCLUDED INFECTION ON HIS LEFT LEG AND ALSO DAMAGE ON HIS KIDNEY. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE WAS ABLE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE SUBJECT METER. REPORTEDLY WHEN THE SUBJECT METERS WERE GIVEN TO THE RETAILER, IT WAS DISCOVERED THAT THE UNIT OF MEASUREMENT WAS INCORRECTLY SET TO MMOL/L. WHEN THE ONETOUCH ULTRA SYSTEM WAS CHECKED WITH CONTROL SOLUTION, THE RESULTS WERE WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PATIENT WAS HOSPITALIZED AND TREATED FOR HYPERGLYCEMIA AFTER THE SUBJECT METERS ALLEGEDLY WERE READING INACCURATELY LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3056179

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R