COBAS 6000 CORE
Received Oct 18, 2011 · Event occurred Sep 8, 2011
Report 1823260-2011-05537 · MDR key 2299093
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05036453001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE QUALITY CONTROL DATA DO NOT SHOW ANY PROBLEMS WITH THE INSTRUMENT OR REAGENT. ADDITIONAL INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION. NO ADVERSE EVENT WAS REPORTED.
Description of Event or Problem
THE CUSTOMER RECEIVED A QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 (TPUC) RESULT ON THEIR C501 ANALYZER. THE ANALYSIS WAS PERFORMED ON A URINE SAMPLE USING THE SAME C501 ANALYZER FOR ALL TESTS. THE PATIENT'S INITIAL TPUC RESULT WAS 1.0 MG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAME SAMPLE WAS PULLED AND RE-TESTED. THE PATIENT'S FIRST REPEAT RESULT WAS 243 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED AND REPEATED. THE SECOND REPEAT RESULT WAS 450 MG/DL. THE CUSTOMER BELIEVED THE REPEAT RESULT OF 450 MG/DL WAS CORRECT AND IT WAS ISSUED AS A CORRECTED REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE TPUC REAGENT LOT NUMBER WAS 63545301 AND THE EXPIRATION DATE WAS 02/29/2012. THE FIELD SERVICE REPRESENTATIVE SUSPECTS THERE WAS AN ISSUE WITH THE PATIENT SAMPLE. HE WAS UNABLE TO DUPLICATE THE ISSUE BECAUSE THE ORIGINAL SAMPLE WAS NOT AVAILABLE. HE INSPECTED THE INSTRUMENT AND THE CUSTOMER PERFORMED A PRECISION STUDY, WHICH PASSED.