MODULAR ANALYTICS CORE
Received Jul 15, 2009 · Event occurred Jun 30, 2009
Report 1823260-2009-04949 · MDR key 1480609
Device
Generic name
Clinical Chemistry Analyzer - Jje
Manufacturer
Roche DiagnosticsModel number
MODULAR CORECatalog number
03739198001
Product problems
- Low Test Results
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER STATES SHE RECEIVED ERRONEOUS RESULTS FOR SODIUM AND SHE RERAN OVER 20 SAMPLES. SHE PROVIDED ONLY THE FOLLOWING 3 PATIENT RESULTS: PATIENT 1, ORIGINAL RESULT 134, REPEAT 140MMOL PER L. PATIENT 2, ORIGINAL RESULT 126, REPEAT 140 MMOL PER L. PATIENT 3, ORIGINAL RESULT 134, REPEAT 149 MMOL PER L. CUSTOMER STATES NONE OF THE ERRONEOUS RESULTS WERE RELEASED TO PHYSICIANS FOR TREATMENT.
Additional Manufacturer Narrative
THE FIELD SERVICE REPRESENTATIVE DETERMINED A DEFECTIVE SIPPER NOZZLE WAS THE CAUSE OF THE DISCREPANCIES AND HE REPLACED THE SIPPER NOZZLE. HE ALSO REPLACED SYRINGE SEALS, PERFORMED ISE SYSTEM CLEANING AND CLEANED VACUUM LINE. HE PERFORMED ISE CHECK AND RAN CALIBRATION AND CONTROLS TO VERIFY ANALYZER OPERATION.