FDA Adverse Event Malfunction Summary report: N

COBAS 6000 CORE

MDR report key: 1083173 · Received July 24, 2008

Report

Report Number
1823260-2008-05767
Event Type
Malfunction
Date Received
July 24, 2008
Date of Event
July 13, 2008
Report Date
July 24, 2008
Manufacturer
ROCHE DIAGNOSTICS CORP.
Product Code
CEM
PMA / PMN Number
K060373
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
MEDICAL TECHNOLOGIST

Narratives

Description of Event or Problem · 1

THIRTEEN PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 1, INITIAL RESULT 130 MMOL/L, REPEAT 141 MMOL/L. PATIENT 2, INITIAL RESULT 129 MMOL/L, REPEAT 138 MMOL/L. PATIENT 3, INITIAL RESULT 126 MMOL/L, REPEAT 136 MMOL/L. PATIENT 4, INITIAL RESULT 134 MMOL/L, REPEAT 144 MMOL/L. PATIENT 5, INITIAL RESULT 128 MMOL/L, REPEAT 138 MMOL/L. PATIENT 6, INITIAL RESULT 130 MMOL/L, REPEAT 139 MMOL/L. PATIENT 7, INITIAL RESULT 129 MMOL/L, REPEAT 138 MMOL/L. PATIENT 8, INITIAL RESULT 130 MMOL/L, REPEAT 139 MMOL/L. PATIENT 9, INITIAL RESULT 130 MMOL/L, REPEAT 141 MMOL. PATIENT 10, INITIAL RESULT 131 MMOL/L, REPEAT 142 MMOL/L. PATIENT 11, INITIAL RESULT 126 MMOL/L, REPEAT 36 MMOL/L. PATIENT 12, INITIAL RESULT 120 MMOL/L, REPEAT 130 MMOL/L. PATIENT 13, INITIAL RESULT 122 MMOL/L, REPEAT 134 MMOL/L. ERRONEOUS RESULTS WERE REPORTED, PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED ROOT CAUSE TO BE A SALT BRIDGE ON THE SIPPER SYRINGE AND CLEANED THE SIPPER SYRINGE AND REPLACED SEALS. HE ALSO NOTED HE CLEANED THE REFERENCE AREA AND REPLACED THE REFERENCE ELECTRODE, REPLACED ISE PINCH TUBING AND SIPPER TUBING. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 UNK