TOTAL PROTEIN GEN.2
Received Jun 17, 2011 · Event occurred May 31, 2011
Report 1823260-2011-03324 · MDR key 2132768
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03183734190
Lot number
63870401
Product problems
- High Test Results
Patient
045 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL ASSAYS INVOLVED IN THIS EVENT ARE REPORTED ON THE MEDWATCH FORMS PATIENT IDENTIFIERS (B)(6).
Description of Event or Problem
THE USER EXPERIENCED CALIBRATION ERRORS AND FLAGGED RESULTS FOR PATIENT SAMPLES FROM THE INTEGRA 800 ANALYZER SERIAL NUMBER (B)(4). THE USER REPEATED TESTING OF THE PATIENT SAMPLES ON THE OTHER INTEGRA 800 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE TOTAL PROTEIN RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 1 INITIAL RESULT WAS 8.5 G/DL AND THE REPEAT RESULT WAS 7.0 G/DL. PATIENT SAMPLE 2 WAS FROM A FEMALE PATIENT BORN ON (B)(6). THE INITIAL RESULT WAS 9.1 G/DL AND THE REPEAT RESULT WAS 7.5 G/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE AND DISCONNECTED LEVEL SENSE CABLE. HE REPLACED THE LIQUID LEVEL SENSE CABLE, WORN ROPES AND A BENT PROBE. HE CONNECTED THE VALVE CABLE ABOVE THE TRANSFER ARM TO THE REAGENT MODULE BODY. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING AND THE USER RAN AND VERIFIED QUALITY CONTROL.