BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1880003 · Received October 19, 2010

    Report

    Report Number
    2432235-2010-00150
    Event Type
    Other
    Date Received
    October 19, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 10

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 10

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 11

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 11

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 12

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 12

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 13

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 13

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 14

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 14

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 15

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 15

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 16

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 16

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 17

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 17

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 18

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 18

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 19

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 19

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 4

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 4

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 5

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 5

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 6

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 6

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 7

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 7

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 8

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 8

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Additional Manufacturer Narrative · 9

    A SIEMENS FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT FT4 AND TSH RESULTS WAS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 9

    MULTIPLE DISCORDANT ADVIA CENTAUR FT4 AND TSH RESULTS WERE ON NINETEEN (19) PT SAMPLES. THE CUSTOMER RECEIVED A CALL FROM A PHYSICIAN STATING THAT THE RESULTS HE RECEIVED DID NOT FIT THE PT'S CLINICAL PICTURE. UPON REVIEWING OTHER RESULTS FOR PT SAMPLES RUN AT THE SAME TIME, THE CUSTOMER REPEATED ALL OF THE FT4 AND TSH SAMPLES. ALL CORRECTED REPORTS WERE REPORTED OUT. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 AND TSH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER JZO SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    10
    11
    12
    13
    14
    15
    16
    17
    18
    19
    2
    3
    4
    5
    6
    7
    8
    9