COBAS 6000 C501MODULE
Received Aug 12, 2010 · Event occurred Jul 29, 2010
Report 1823260-2010-04804 · MDR key 1797432
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
090 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "DEFIB FAULT 72", "DEFIB FAULT 76," AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE CAUSE OF THE OBSERVED DISCREPANCY MAY BE THE PATIENT'S MYELOMA SINCE MYELOMAS MAY LEAD TO ABNORMAL REACTION KINETICS CAUSED BY A MONOCLONAL ANTIBODY. AS NEITHER THE SAMPLE IN QUESTION NOR THE REACTION MONITOR WAS AVAILABLE, FURTHER INVESTIGATION WAS NOT POSSIBLE. A ROOT CAUSE COULD NOT BE IDENTIFIED. THE PATIENT WAS NOT AFFECTED BY THE EVENT.
Description of Event or Problem
THE USER RECEIVED A QUESTIONABLE IGA RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 43.42 G/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER AND GAVE A REPEAT RESULT OF 0.42 G/L. DUE TO THE DIFFERENCE IN THE RESULTS, THE USER REPEATED THE SAMPLE WITH A MANUAL DILUTION AND RECEIVED A RESULT OF 71.8 G/L. A RESULT OF 83 G/L WITH A DATA FLAG WAS GENERATED FROM A 1:100 DILUTION AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE IGA REAGENT LOT NUMBER WAS 630098.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN THE (B)(6).