BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS FAST HTSH REAGENT

    MDR report key: 4614034 · Received March 18, 2015

    Report

    Report Number
    2122870-2015-00158
    Event Type
    Injury
    Date Received
    March 18, 2015
    Date of Event
    November 14, 2014
    Report Date
    February 23, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JLW
    PMA / PMN Number
    K042281
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE PATIENT'S WEIGHT. THE PATIENT WAS PRESCRIBED A LOWER DOSE OF THYROXIN THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE ACCESS FAST HTSH REAGENT IN USE FOR THIS EVENT. THE EXPIRATION DATE AND DATE OF MANUFACTURE OF THE ACCESS FAST HTSH REAGENT CANNOT BE DETERMINED. THE ACCESS FAST HTSH REAGENT WAS NOT RETURNED FOR EVALUATION. THE PATIENT'S SAMPLE WAS SENT TO BECKMAN COULTER COMPLAINT HANDLING UNIT (CHU) FOR TESTING. TESTING OF THE CUSTOMER-SUPPLIED NEAT SAMPLE CONFIRMED THE CUSTOMER'S RESULTS. FURTHER TESTING OF THE SAMPLE, WITH BLOCKER PROTEINS SPECIFIC TO ALKALINE PHOSPHATASE AND ANIMAL DERIVED ANTIBODIES REDUCED THE ELEVATED RESULT BY 30-80% CONFIRMING THE PRESENCE OF A PATIENT SOURCE INTERFERENT. IN CONCLUSION, INTERFERENCE IS THE CAUSE OF THE ELEVATED ACCESS FAST HTSH RESULTS REPORTED BY THE CUSTOMER FOR THIS PATIENT BECKMAN COULTER (BEC) INTERNAL PATIENT IDENTIFIER FOR THIS REPORT IS CF150223-093 (001) ALL MDRS ASSOCIATED WITH THIS REPORT ARE: 2122870-2015-00157; 2122870-2015-00158; 2122870-2015-00159; 2122870-2015-00160; 2122870-2015-00161; 2122870-2015-00162.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING REPRODUCIBLY ELEVATED THYROID-STIMULATING HORMONE (ACCESS FAST HTSH) RESULTS ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THIS REPORT ADDRESSES THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED ON (B)(6) 2014. THE PATIENT WAS PREVIOUSLY PRESCRIBED THYROXIN AS THEY HAD BEEN DIAGNOSED AS HYPOTHYROID. THERE WAS A CHANGE IN THE PATIENT'S TREATMENT AS THE THYROXIN DOSE WAS REDUCED DUE TO THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED. ADDITIONAL ACCESS FAST HTSH ANALYSES OF THE PATIENT'S SAMPLE FROM DIFFERENT DRAWS, ON DIFFERENT DAYS WERE PERFORMED ON THE SAME UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND ALL RECOVERED WITH REPRODUCIBLY ELEVATED RESULTS. MDR2122870-2015-00157 ADDRESSES THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED ON (B)(6) 2014; MDR2122870-2015-00159 ADDRESSES THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED ON (B)(6) 2014; MDR2122870-2015-00160 ADDRESSES THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED ON (B)(6) 2014; MDR2122870-2015-00161 ADDRESSES THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED ON (B)(6) 2014; MDR2122870-2015-00162 ADDRESSES THE ELEVATED ACCESS FAST HTSH RESULT OBTAINED ON (B)(6) 2015 ON THE CUSTOMER'S ALTERNATE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER QUESTIONED THE ELEVATED ACCESS FAST HTSH RESULTS AS THE PATIENT'S RESULTS WERE NOT DECREASING AS WOULD BE EXPECTED WITH A REDUCTION IN THYROXIN DOSAGE. THE CUSTOMER DILUTED THE PATIENT'S SAMPLE AND THE RESULT OBTAINED WAS NOT LINEAR. AS NON-LINEAR RESULTS MAY INDICATE INTERFERENCE, THE CUSTOMER SENT THE PATIENT'S SAMPLE OBTAINED ON (B)(6) 2015 TO ANOTHER LABORATORY UTILIZING THE ROCHE METHODOLOGY, AND A RESULT WITHIN THE CUSTOMER'S EXPECTED RANGE WAS OBTAINED. THE CUSTOMER SENT THE SAME PATIENT'S SAMPLE TO BECKMAN COULTER COMPLAINT HANDLING UNIT (CHU) FOR ADDITIONAL TESTING. ALL SYSTEM PARAMETERS (INCLUDING QUALITY CONTROL (QC), CALIBRATION AND SYSTEM CHECK) HAVE BEEN RECOVERING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE PATIENT'S SAMPLE WAS COLLECTED IN A SERUM TUBE AND CENTRIFUGED AT 3500 RPM. (REVOLUTIONS PER MINUTE) FOR SEVEN MINUTES AT 24 DEGREES CENTIGRADE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT PROVIDE INFORMATION ON WHICH OF THE LABORATORY'S TWO UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMS (B)(4) WAS IN USE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185190 ACCESS FAST HTSH REAGENT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE, PRODUCT CODE: JLW JLW BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other