BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION OPTIUM EZ

    MDR report key: 1780049 · Received August 2, 2010

    Report

    Report Number
    2954323-2010-01044
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 10, 2010
    Report Date
    September 24, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: THE REPORTED READINGS OF 220 MG/DL AND 33 MG/DL WERE NOT COMPLETED WITHIN 10 MINUTES. THE DATE OF MANUFACTURE IS UNKNOWN. THE REPORTED DATE IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. DISASSEMBLED THE METER AND FOUND NO CONTAMINATION IN STRIP PORT. REPLACED STRIP PORT WITH KNOWN GOOD STRIP PORT. METER FUNCTIONED PROPERLY UPON BUTTON DEPRESSION AND STRIP INSERTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER'S NURSE REPORTED CUSTOMER RECEIVED A READING OF 220 MG/DL FROM THEIR PRECISION XTRA METER WHICH WAS HIGHER WHEN COMPARED TO ANOTHER METER. CUSTOMER'S NURSE ALSO REPORTED CUSTOMER WAS FOUND UNCONSCIOUS IN BED AND CUSTOMER'S NURSE RECEIVED A READING OF 220 MG/DL FROM THEIR METER. PARAMEDICS WERE CALLED AND THEY OBTAINED A READING OF 33 MG/DL FROM THEIR HCP METER. CUSTOMER'S NURSE STATED THAT SHE BELIEVED CUSTOMER WAS GIVEN GLUCAGON INJECTION IN THE AMBULANCE. CUSTOMER'S NURSE FURTHER REPORTED CUSTOMER WAS TAKEN TO A HEALTH CARE FACILITY WHERE CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA; HOWEVER, NO THIRD PARTY MEDICAL INTERVENTION WAS REPORTEDLY GIVEN AT THE HEALTH CARE FACILITY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THERE WAS FIBER BREAKAGE AT 20,732 JOULES. ALL PIECES OF THE BROKEN TIP WERE RETRIEVED AND NO PT INJURY WAS REPORTED. AN EXAMINATION, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, CONFIRMED THAT THE CAP HAD FRACTURED AND HAD PARTIALLY BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION OPTIUM EZ BLOOD GLUCOSE MONITORING SYSTEM NBW 45789 / 45678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other