ELECSYS BRAHMS PCT
Received Dec 7, 2017 · Event occurred Nov 16, 2017
Report 1823260-2017-02870 · MDR key 7095868
Device
Generic name
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05056888200
Lot number
204084
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. ROCHE HAS INFORMED THE CUSTOMER OF POSSIBLE DISCREPANCIES WITH PROCALCITONIN RESULTS BETWEEN THE COBAS E801 AND OTHER ROCHE ANALYZERS AND ADVISED THE CUSTOMER TO DISCONTINUE TESTING ON THE COBAS E801. A RECALL WAS INITIATED.
Additional Manufacturer Narrative
(B)(4). (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS BRAHMS PCT (PROCALCITONIN) RESULTS FROM A COBAS 8000 E801 MODULE. THE ANALYZER SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER SAID THE ISSUE OCCURRED WITH 10 OUT OF 1000 SAMPLES PER MONTH. THE CUSTOMER USED SERUM, EDTA PLASMA, AND CITRATE PLASMA FROM THE PATIENT AND RETESTED THE SAMPLES AFTER SEVERAL HOURS. THE CUSTOMER ALSO TESTED THE SAMPLES BY SQH METHOD AND RETESTED AFTER ADDITION TO A COAGULATION ACCELERATION TUBE (THROMBIN + HEPARIN NEUTRALIZING AGENT). THE CUSTOMER ALSO PERFORMED EXPERIMENTS OF MIXING SEVERAL SAMPLES WHICH SHOWED PROCALCITONIN INCREASE. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER SPECULATED THAT ANTI-PROCALCITONIN ANTIBODY MAY BE CAUSING AGGLUTINATION WITH SERUMS CONTAIN HIGH MICRO-FIBRIN.
Remedial action
- Recall