BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXSYM PROLACTIN REAGENT

    MDR report key: 77334 · Received March 14, 1997

    Report

    Report Number
    1415939-1997-00006
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    November 14, 1996
    Report Date
    March 14, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    # 2698530-01 THIS COMPLAINT IS LINKED WITH ID#2712929. NO CUSTOMER RETURN RECEEIVED. TO INVESTIGATE THIS COMPLAINT AXSYM PROLACTIN REAGENT PACK LOT 16594M300 WAS TESTED WITH A HIGH DOSE HOOK (HDH) PANEL, RUN UNDILUTED AND DILUTED 1:200 IN PROLACTIN A CALIBRATOR. THE INVESTIGATION RESULTS FROM THE HDH PANEL MET AND EXCEEDED THE PACKAGE INSERT CLAIM OF BEING ABLE TO ASSAY UP TO 10,000 NG/ML WITHOUT OBSERVING A HIGH DOSE HOOK EFFECT. THE AXSYM PROLACTIN PACKAGE INSERT ADDRESSES THE HIGH DOSE HOOK LIMITATION OF THE ASSAY BY STATING, "SAMPLES WITH PROLACTIN CONCENTRATIONS UP TO 10,000 NG/ML CAN BE ASSAYED WITHOUT EXPERIENCING A HIGH DOSE HOOK EFFECT. IN SOME RARE PATHOLOGICAL CONDITIONS, PROLACTIN CONCENTRATIONS MAY EXCEED 10,000 NG/ML THESE SPECIMENS MAY READ LOWER THAN THE HIGHEST CALIBRATOR AN SHOULD BE DILUTED PRIOR TO PIPETTING THE SAMPLE INTO THE SAMPLE WELL." THE CUSTOMER OBSERVED A READING OF 118 NG/ML ON A UNDILUTED SAMPLE FROMA MALE PT WITH A KNOWN PITIUTARY TUMOR. ON THE SAME SAMPLE, THE CUSTOMER OBSERVED A POSSIBLE HIGH DOSE HOOK EFFECT (CODE 86), AT A REPORTED CONCENTRATION OF 17,500 NG/ML, GREATER THAN THE 10,000 NG/ML CLAIM OF THE ASSAY. NO CORRECTIVE ACTION REQUIRED. AXSYM PROLATIN PACKAGE INSERT CLAIMS WRE MET IN BOTH THE CUSTOMER'S TESTING AND THE INVESTIGATION TESTING. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 11/14/96, THE ACCOUNT REPORTED A PROLACTIN RESULT OF 118 NG/ML AND THE PT HAD PITUITARY TUMOR REMOVED BASED ON THIS RESULT. THE DATE OF SURGERY IS UNKNOWN. ON 2/13/97, THE PHYSICIAN INFORMED THE ACCOUNT THAT HE HAD SENT A SAMPLE FROM THE PT TO ANOTHER LAB AND A RESULT OF 17,500 NG/ML WAS RECEIVED. ACCORDING TO THE ACCOUNT, THE PT'S SURGEON STATED HE DID NOT RECEIVE THE 17,500 NG/ML RESULT UNTIL AFTER SURGERY AND WOULD NOT HAVE OPERATED IF HE KNEW THE PROLACTIN WAS THAT HIGH. AFTER RECEIVING THIS INFO, ACCOUNT THAWED THE SAMPLE FROM 11/14/96 AND RERAN IT. RESULTS OF 111.7 AND 112 NG/ML WERE RECEIVED. THE ACCOUNT READ THE PACKAGE INSERT, WHICH STATED A HIGH DOSE HOCK EFFECT CAN BE SEEN IN RARE PATHOLOGICAL CONDITIONS. PROLACTIN CONCENTRATIONS EXCEEDING 10,000 NG/ML MAY READ LOWER THAN HIGHEST CALIBRATOR AND SHOULD BE DILUTED MANUALLY. THR SAMPLE WAS DILUTED AND THE FOLLOWING RESULTS WERE OBTAINED: 1:50 GREATER THAN 200; 1:100 GREATER THAN 1:200; 1:200 GREATER THAN 200; 1:250 = 44,000; AND 1:300 = 43,500 NG/ML. THE ACCOUNT IS NOW DILUTING ALL PROCLATIN SAMPLES THAT READ GREATER THAN 200 NG/ML. FURTHER PT INFO HAS BEEN PROVIDED BY ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM PROLACTIN REAGENT MICROPARTICLKE ENZYME IMMUNOASSAY CFT ABBOTT LABORATORIES NA 16594M300

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other