BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI CCA-TS2

    MDR report key: 4684334 · Received April 9, 2015

    Report

    Report Number
    3004102403-2015-00001
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    February 23, 2015
    Report Date
    April 9, 2015
    Manufacturer
    OPTI MEDICAL SYSTEMS INC.
    Product Code
    GKR
    PMA / PMN Number
    K131126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE TESTS FROM THE HOSP IN (B)(6) WERE REVIEWED BY OPTI INVESTIGATION TEAM. IT IS WELL UNDERSTOOD THAT HEMODIALYSIS CAN AFFECT THB. DURING REVIEW OF THE OTHER BLOOD RESULTS GENERATED ON THE AFFECTED DEVICE, IT WAS NOTED THAT THE LEVEL OF POTASSIUM MEASUREMENT WAS HIGH OUT OF RANGE IN THE FIRST SAMPLE RUN. A HIGH POTASSIUM LEVEL IS CONSISTENT WITH BLOOD SAMPLES THAT HAVE HEMOLYZED. SAMPLING DEVICES AND LOANER S/N (B)(4) WERE SENT TO THE CUSTOMER. THE AFFECTED ANALYZER, S/N (B)(4), WAS RETURNED TO OPTI FOR INVESTIGATION. THE INVESTIGATION OF THE ISSUE USING WIDER RANGE OF ANALYZERS DETERMINED THAT SOME ANALYZERS SHOW A POSITIVE BIAS IN THE THB MEASUREMENT THAT EXCEEDS OUR SPECIFICATION AT LOW SO2 VALUES. THE INVESTIGATION ALSO CONCLUDED THAT THE POSITIVE BIAS MAY BE THE RESULT OF A CHANGE IN ONE OF THE COMPONENTS USED IN THE THB MEASUREMENT SYSTEM OF THE ANALYZER. AS PART OF THE ONGOING INVESTIGATION, RESULTS FROM REPEAT TESTS RUN BY THE CUSTOMER USING APPROPRIATE SAMPLING DEVICES ON S/N (B)(4) AGAINST I-STRAT REFERENCE AND OBSERVED POSITIVE 2.5 G/DL TO 3.5 G/DL BIAS ON SEVERAL SAMPLES ON (B)(4) 2015. OPTI TECHNICAL PERSONNEL VISITED THE HOSP TO OBSERVE THE SAMPLING AND THE TESTING WAS REPEATED ON (B)(4) 2015. THE POSITIVE BIAS WAS REPRODUCED. OPTI MEDICAL IS INITIATING A FIELD CORRECTION AND REMOVAL CUSTOMER NOTIFICATION IN WHICH CUSTOMERS WILL BE REQUESTED TO NOT REPORT THB RESULTS WHEN USING OPTI CCA-TS2 ANALYZER DUE TO A POSITIVE BIAS IN THB. HEALTHCARE PROFESSIONAL DR TIM SKELTON (CLINICAL PATHOLOGIST) STATED THAT A POSITIVE BIAS IN THB RESULT MAY LEAD TO DELAYED TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, OPTI MEDICAL CONFIRMED A CUSTOMER COMPLAINT FROM (B)(6). CUSTOMER REPORTED POSITIVE BIAS BETWEEN 5 G/DL TO 7 G/DL IN THB MEASUREMENT RELATIVE TO THE PT'S HEMATOLOGY RESULTS WHEN USING OPTI TS2 S/N (B)(4). THERE WAS NO ADVERSE IMPACT TO THE PT'S HEALTH CONDITION DUE TO THIS BIAS. THE DISCREPANT RESULT FROM THE ANALYZER WAS NOT USED TO MAKE A MED DECISION, E.G. DIAGNOSIS OR TREATMENT. THE DR INDICATED THAT THE DISCREPANT RESULT WAS READILY APPARENT AND THE PT BLOOD RETESTED USING A DIFFERENT INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233957 OPTI CCA-TS2 GKR OPTI MEDICAL SYSTEMS INC. OPTI 6

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR