ELECSYS ANTI-CCP IMMUNOASSAY
Received Jun 5, 2020 · Event occurred Jan 25, 2020
Report 1823260-2020-01371 · MDR key 10123507
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05031656190
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER'S CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DISCOVERED PATTERNS OF DISCREPANT RESULTS BETWEEN SERUM AND PLASMA SAMPLES FROM THE SAME BLOOD DRAW OF A GIVEN PATIENT: NEGATIVE RESULTS OR RESULTS BELOW THE CUTOFF VALUE ON SERUM SAMPLES AND POSITIVE RESULTS ON PLASMA SAMPLES. ALSO, THE CONCENTRATIONS OBTAINED FROM PLASMA SAMPLES ARE DEPENDENT ON THE REAGENT LOTS USED FOR TESTING. FURTHER INVESTIGATIONS WERE CONDUCTED AND THE INVESTIGATION COULD NOT IDENTIFY THE ROOT CAUSE.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-CCP IMMUNOASSAY RESULT FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY TO A CLINICIAN. THE CLINICIAN WAS ALERTED OF THE QUESTIONABLE RESULT DUE TO THE RESULT NOT MATCHING THE PATIENT'S CLINICAL PICTURE AND RHEUMATOID FACTOR RESULTS. THE PATIENT'S SERUM SAMPLE WAS TESTED FOR CONFIRMATION. THE PATIENT¿S ANTI-CCP RESULT WITH A PLASMA SAMPLE WAS "WEAK POSITIVE." THE PATIENT¿S ANTI-CCP RESULT WITH A SERUM SAMPLE WAS "NEGATIVE" (<7 IU/ML). THE PATIENT'S SERUM RESULT WAS DETERMINED CORRECT. THE E 601 MODULE SERIAL NUMBER IS (B)(4).