FDA Adverse Event Malfunction Summary report: N

COBAS 6000 C501 MODULE

MDR report key: 1051417 · Received May 19, 2008

Report

Report Number
1823260-2008-04208
Event Type
Malfunction
Date Received
May 19, 2008
Date of Event
May 6, 2008
Report Date
May 21, 2008
Manufacturer
ROCHE DIAGNOSTICS
Product Code
CEM
PMA / PMN Number
K060373
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
HEALTH PROFESSIONAL

Narratives

Description of Event or Problem · 1

TWENTY-SEVEN PATIENTS WITH DISCREPANT SODIUM AND/OR BICARBONATE RESULTS. PATIENT 1, INITIAL SODIUM RESULT 130 MMOL/L, REPEATED TWICE 138 AND 133 MMOL/L; INITIAL BICARBONATE RESULT 22 MMOL/L, REPEATED TWICE 14.3 AND 17.1 MMOL/L. PATIENT 2, INITIAL BICARBONATE RESULT 21 MMOL/L, REPEAT 16.8 AND 19.2 MMOL/L. PATIENT 3, INITIAL SODIUM RESULT 133 MMOL/L, REPEATED TWICE 140 AND 136 MMOL/L; INITIAL BICARBONATE RESULT 20 MMOL/L, REPEATED TWICE 13.4 AND 15.5 MMOL/L. PATIENT 4, INITIAL BICARBONATE RESULT 25.9 MMOL/L, REPEATED TWICE 19.9 AND 22.1 MMOL/L. PATIENT 5, INITIAL BICARBONATE RESULT 20.8 MMOL/L, REPEATED TWICE 14.8 MMOL/L, REPEAT 17.1 MMOL/L. PATIENT 6, INITIAL SODIUM RESULT 126 MMOL/L, REPEATED TWICE 132 AND 128 MMOL/L; INITIAL BICARBONATE RESULT 22.9 MMOL/L, REPEATED TWICE 16.6 AND 18.4 MMOL/L. PATIENT 7, INITIAL SODIUM RESULT 132 MMOL/L, REPEATED TWICE 141 AND 134 MMOL/L; INITIAL BICARBONATE RESULT 21.7 MMOL/L, REPEATED TWICE 14.4 AND 16.9 MMOL/L. PATIENT 8, INITIAL BICARBONATE RESULT 29.5 MMOL/L, REPEATED TWICE 18.7 AND 27.1 MMOL/L. PATIENT 9, INITIAL BICARBONATE RESULT 23.7 MMOL/L, REPEATED TWICE 18.9 AND 19.7 MMOL/L. PATIENT 10, INITIAL BICARBONATE RESULT 24.4 MMOL/L, REPEATED TWICE 19.2 AND 19.9 MMOL/L. PATIENT 11, INITIAL BICARBONATE RESULT 22.6 MMOL/L, REPEATED TWICE 17.7 AND 19.0 MMOL/L. PATIENT 12, INITIAL SODIUM RESULT 134 MMOL/L, REPEAT 145 MMOL/L; INITIAL BICARBONATE RESULT 19.4 MMOL/L, REPEAT 14.2 MMOL/L. PATIENT 13, INITIAL BICARBONATE 23.5, REPEATED TWICE 18.0 AND 19.9 MMOL/L. PATIENT 14, INITIAL BICARBONATE RESULT 19.2 MMOL/L, REPEATED TWICE 14.0 AND 15.7 MMOL/L. PATIENT 15, INITIAL BICARBONATE RESULT 27.5, REPEATED THREE TIMES 25.8, 20.3 AND 21.0 MMOL/L. PATIENT 16, INITIAL BICARBONATE RESULT 20.2 MMOL/L, REPEAT 15.8 MMOL/L. PATIENT 17, INITIAL SODIUM RESULT 132 MMOL/L, REPEATED TWICE 140 AND 137 MMOL/L; INITIAL BICARBONATE RESULT 25.9 MMOL/L, REPEATED TWICE 18.6 AND 19.9 MMOL/L. PATIENT 18, INITIAL BICARBONATE RESULT 20.3 MMOL/L, REPEATED TWICE 14.4 AND 15.4 MMOL/L. PATIENT 19, INITIAL BICARBONATE RESULT 20.4 MMOL/L, REPEATED TWICE 15.8 AND 17.3 MMOL/L. PATIENT 20, INITIAL SODIUM RESULT 134 MMOL/L, REPEATED THREE TIMES 153, 137, AND 138 MMOL/L. PATIENT 21, INITIAL BICARBONATE RESULT 19.4 MMOL/L, REPEATED TWICE 13.8 AND 14.8 MMOL/L. PATIENT 22, INITIAL SODIUM RESULT 134 MMOL/L, REPEATED TWICE 155 AND 156 MMOL/L; INITIAL BICARBONATE 31.3 MMOL/L, REPEAT 24.5 MMOL/L. PATIENT 23, INITIAL BICARBONATE RESULT 26.0 MMOL/L, REPEATED TWICE 18.4 AND 20.4 MMOL/L. PATIENT 24, INITIAL BICARBONATE RESULT 24.8 MMOL/L, REPEATED TWICE 16.5 AND 19.0 MMOL/L. PATIENT 25, INITIAL BICARBONATE RESULT 25.7 MMOL/L, REPEATED TWICE 17.5 AND 20.3 MMOL/L. PATIENT 26, INITIAL BICARBONATE RESULT 25.0 MMOL/L, REPEATED TWICE 15.6 AND 19.3 MMOL/L. PATIENT 27, INITIAL BICARBONATE RESULT 24.1 MMOL/L, REPEATED TWICE 16.3 AND 18.0 MMOL/L. INITIAL RESULTS WERE REPORTED, PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE BUT QUESTIONED PROPER HANDLING AND STORAGE OF SAMPLES PRIOR TO RE-RUNNING. PERFORMANCE TESTS WERE PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501

Patients

Seq Age Sex Outcome Treatment
1 UNK