MalfunctionJCB
ELECSYS CLEAN CELL
Received Sep 9, 2004 · Event occurred Jun 25, 2004
Report 1823260-2004-00884 · MDR key 546481
Device
Generic name
General Purpose Reagent
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11662970122
Lot number
14390100
Product problems
- Incorrect Or Inadequate Test Results
Patient
* NP
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A BOTTLE DEFECT PREVENTED NORMAL DESCENT OF THE SIPPER PROBE PRODUCING INSTRUMENT ALARMS AND CAUSING DISCREPANT RESULTS FOR NINE PT SAMPLES THAT WERE BEING TESTED FOR HCG, TROPONIN T, CKMB OR MYOGLOBIN. THE OPERATOR NOTICED THE BOTTLE DEFECT, EXCHANGED THE BOTTLE AND REPEATED THE AFFECTED SAMPLES. THE BOTTLE MANUFACTURER HAS IMPLEMENTED A VIDEO CONTROL SYSTEM TO PREVENT FUTURE OCCURRENCES.
Remedial action
- Replace