BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 1984153 · Received February 10, 2011

    Report

    Report Number
    2939301-2011-01275
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    February 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K061118. 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/SUPPLEMENTAL REPORT TEXT 02/25/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    A PHARMACY CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON A PATIENT'S ONE TOUCH ULTRAMINI METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PHARMACY DID NOT KNOW THE PATIENT'S PHONE # FOR LFS TO CONTACT THE PATIENT TO OBTAIN FURTHER CLINICAL INFORMATION. THE PHARMACY COULD ONLY PROVIDE THE FOLLOWING INFORMATION. THE PATIENT WAS IN THE HOSPITAL FOR A HEART OPERATION. WHILE HER STAY IN THE HOSPITAL, THE PATIENT TESTED ON HER METER AND OBTAINED A 300 MG/DL. THE PATIENT HAD TAKEN INSULIN BASED ON THE LFS METER READING AND AT AN UNSPECIFIED TIME LATER DEVELOPED SYMPTOMS OF "LOW BLOOD SUGAR LEVELS". IT IS UNKNOWN WHAT SYMPTOMS THE PATIENT EXPERIENCED OR WHAT TREATMENT SHE RECEIVED IN THE HOSPITAL. THE PATIENT WAS TESTED IN THE LAB AND OBTAINED 150 MG/DL. IT IS UNKNOWN WHETHER THE 150 MG/DL WAS BEFORE TREATMENT OR AFTER TREATMENT. IT IS UNKNOWN ON THE CONDITIONS OF HER TESTING SUPPLIES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE DEVELOPED SYMPTOMS OF "LOW BLOOD SUGAR LEVELS" AFTER TAKING INSULIN BASED ON HER METER READING OF 300 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043355

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R