BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2020646 · Received March 16, 2011

    Report

    Report Number
    2939301-2011-02287
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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

    FOLLOW-UP # 1 (03/23/11)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WAS REQUESTED BUT HAS NOT BEEN RETURNED TO LIFESCAN. THE METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE RETURNED METER PASSED ALL TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS ALSO COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 ALLEGING INACCURATE LOW READINGS ON HIS ONE TOUCH ULTRA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL TO GET A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE PATIENT MENTIONED THAT ON (B)(6) 2011 AT AROUND 1:00PM, HE TESTED HIS BLOOD GLUCOSE ON HIS LFS METER AND OBTAINED A 14.6 AND LESS THAN 30 MINUTES LATER TESTED ON ANOTHER ULTRA METER AND OBTAINED A 255 MG/DL. AT AN UNSPECIFIED TIME LATER THE PATIENT ENDED UP GOING INTO A DIABETIC COMA. HE ENDED UP GOING TO THE HOSPITAL WITH A BLOOD GLUCOSE OF 778 MG/DL WHERE HE WAS "IN AND OUT" AND WAS VOMITING. THE PATIENT WAS TREATED WITH INSULIN EVERY 45 MINUTES AND WAS ALSO GIVEN SODIUM IN THE HOSPITAL. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE PRODUCT WAS REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, EVENTS LEADING TO THE SYMPTOMS, AND HOW LONG THE PATIENT WAS IN THE HOSPITAL. IT WOULD HAVE ALSO BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN AND WHETHER HIS DIABETES MEDICATION WAS CHANGED DUE TO THE ALLEGED ISSUE. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED LOW READING, HE DEVELOPED SYMPTOMS AND WAS HOSPITALIZED FOR A BLOOD GLUCOSE OF 778 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3092813

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R