BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1984466 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00230
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 9, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED SINCE CUSTOMER REPORTED RESULTS THAT WERE TAKEN A DAY APART. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT ACCURACY CRITERIA WAS MET. PER GENERAL DESCRIPTION OF COMPLAINT, PATIENT REPORTED CONSUMING LARGE AMOUNTS OF SPINACH AND BROCCOLI AT RANDOM INTERVALS. PER TECHNICAL BULLETIN, SPINACH AND BROCCOLI CONTAIN HIGH AMOUNTS OF VITAMIN K, WHICH CAN HAVE AN IMPACT ON SERUM VITAMIN K LEVELS AND CAUSE INR RESULTS TO DROP. AS OF 01/31/2011, SEVENTY DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243934, YIELDING A COMPLAINT RATE OF 0.052%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT #243934. GREATER THAN +/- 1.0 BIAS WAS OBTAINED ON RETURNED UNIT. TWO MORE DONORS WILL BE TESTED TO ELIMINATE THE POSSIBILITY THAT THE FAILURE IS DUE TO DONOR SPECIFIC EFFECT. ADDITIONAL ACCURACY TESTING PERFORMED ON (B)(6) 2011. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND SYSMEX INRS WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT #243934 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW RESULTS ON INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.9. DATE: (B)(6) 2011, INRATIO: 1.9. PATIENT TESTED A COUPLE OF DAYS IN A ROW AND GOT THE SAME RESULT EACH TIME. AFTER EACH TEST, HE SELF-ADJUSTED HIS COUMADIN DOSE, BUT THAT DID NOT CHANGE HIS INR. PATIENT MENTIONED EATING A LOT OF SPINACH AND BROCCOLI AT RANDOM INTERVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other