BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1569791 · Received January 5, 2010

    Report

    Report Number
    2954323-2010-00008
    Event Type
    Injury
    Date Received
    January 5, 2010
    Date of Event
    December 6, 2009
    Report Date
    July 12, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMERS RETURNED METER (B) (4) WAS INVESTIGATED. METER DATA-LOG WAS UPLOADED AND REVIEWED AND SIGNIFICANT DATE AND TIME CHANGES WERE OBSERVED. TIME AND DATE CHANGE DUE TO ELECTRO STATIC DISCHARGE WAS OBSERVED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: DURING THE COURSE OF TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, THE CUSTOMER WAS ABLE TO REPEAT THE CALIBRATION, AND IT WAS SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH THE OFFICE OF SURVEILLANCE AND BIOMETRICS AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(6) 2011 LETTER ADDRESSED TO (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED AND EXTENDED INVESTIGATIONS HAVE BEEN COMPLETED. THE COMPLAINT WAS NOT CONFIRMED. AFTER REVIEW OF THE METER DATA LOG IT HAS BEEN DETERMINED THAT SIGNIFICANT DATE AND TIME CHANGES WERE NOT OBSERVED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW HEMOGLOBIN (HGB) AND HIGH PLATELETS (PLT) RESULTS ON TWO DIFFERENT PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. AFTER REVIEWING THE PATIENTS' RERUN RESULTS FROM A DIFFERENT INSTRUMENT, THE OPERATOR NOTICED DISCREPANT RESULTS. THE LAB SENT OUT CORRECTED REPORTS BEFORE PATIENT TREATMENT COULD BE AFFECTED. NO CHANGE TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERROR 6 MESSAGE ON THEIR PRECISION XTRA METER. THE CUSTOMER EXPERIENCED "LOW BLOOD SUGAR" AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER REPORTED THERE WAS A DELAY/CHANGE IN TREATMENT AS A RESULT OF THIS ISSUE. THE CUSTOMER SELF TREATED WITH FOOD. NO THIRD PARTY MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WENT OUT DURING A CASE, CAUSING A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 44454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other