FDA Adverse Event Malfunction Summary report: N

COBAS INTEGRA 400

MDR report key: 1019668 · Received March 21, 2008

Report

Report Number
1823260-2008-02657
Event Type
Malfunction
Date Received
March 21, 2008
Date of Event
February 27, 2008
Report Date
March 21, 2008
Manufacturer
ROCHE DIAGNOSTICS
Product Code
JJE
PMA / PMN Number
K951595
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
HEALTH PROFESSIONAL

Narratives

Description of Event or Problem · 1

USER REPORTS OVER TWENTY PTS WITH DISCREPANT SODIUM RESULTS. EIGHTEEN EXAMPLES WERE PROVIDED, INITIAL TESTING FOR TWO DAYS IN 2008, REPEAT TESTING ON THE SECOND DAY: PATIENT 1, INITIAL RESULT 117 MMOL/L, REPEAT GAVE 123 MMOL/L. PATIENT 2, INITIAL RESULT 128 MMOL/L, REPEAT GAVE 136 MMOL/L. PATIENT 3, INITIAL RESULT 130 MMOL/L, REPEAT GAVE 136 MMOL/L. PATIENT 4, INITIAL RESULT 126 MMOL/L, REPEAT GAVE 136 MMOL/L. PATIENT 5, INITIAL RESULT 129 MMOL/L, REPEAT GAVE 137 MMOL/L. PATIENT 6, INITIAL RESULT 126 MMOL/L, REPEAT GAVE 136 MMOL/L. PATIENT 7, INITIAL RESULT 134 MMOL/L, REPEAT GAVE 143 MMOL/L. PATIENT 8, INITIAL RESULT 128 MMOL/L, REPEAT GAVE 137 MMOL/L. PATIENT 9, INITIAL RESULT 130 MMOL/L, REPEAT GAVE 139 MMOL/L. PATIENT 10, INITIAL RESULT 131 MMOL/L, REPEAT GAVE 137 MMOL/L. PATIENT 11, INITIAL RESULT 133 MMOL/L, REPEAT GAVE 140 MMOL/L. PATIENT 12, INITIAL RESULT 134 MMOL/L, REPEAT GAVE 142 MMOL/L. PATIENT 13, INITIAL RESULT GAVE MMOL/L, REPEAT GAVE 137 MMOL/L. PATIENT 14, INITIAL RESULT 129 MMOL/L, REPEAT GAVE 138 MMOL/L. PATIENT 15, INITIAL RESULT 126 MMOL/L, REPEAT GAVE 133 MMOL/L. PATIENT 16, INITIAL RESULT 131 MMOL/L, REPEAT GAVE 140 MMOL/L. PATIENT 17, INITIAL RESULT 131 MMOL/L, REPEAT GAVE 141 MMOL/L. PATIENT 18, INITIAL RESULT 124 MMOL/L, REPEAT GAVE 132 MMOL/L. THE INITIAL RESULTS WERE REPORTED, THE PTS WERE NOT ADVERSELY AFFECTED. THE CAUSE WAS UNDETERMINED, MAINTENANCE AND TROUBLESHOOTING WERE PERFORMED. IT WAS ALSO NOTED ANALYZER WAS RECONFIGURED TO RUN QUALITY CONTROL AFTER EVERY CALIBRATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400

Patients

Seq Age Sex Outcome Treatment
1