COBAS B 221<6>=ROCHE OMNI S6 SYSTEM
Received Apr 11, 2014 · Event occurred Mar 18, 2014
Report 1823260-2014-02591 · MDR key 3745842
Device
Generic name
Blood Gas Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03337154001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLY LOW TOTAL HEMOGLOBIN RESULTS ON THEIR B221 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT WITH A DISCREPANT RESULT. THE PATIENT'S INITIAL TOTAL HEMOGLOBIN RESULT WAS 8.7 G/DL AND IT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER STATED THAT IN THE "PEDIATRIC INTENSIVE ROOM", THE DOCTORS COMPLAINED THAT THE VALUE OF TOTAL HEMOGLOBIN WAS VERY LOW AND SHOULD BE AROUND 13 G/DL. THE SAMPLE WAS REPEATED WITH A SYSMEX HEMATOLOGY AUTOMATED ANALYZER, MODEL XE2100. THE REPEAT RESULT WAS 12 G/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE TOTAL HEMOGLOBIN CARTRIDGE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. DURING THE EVALUATION OF THE ANALYZER, IT WAS FOUND THAT THERE WAS A LAYER OF BROWN COLOR ON THE WALLS OF THE CUVETTE. THE CLEANING PROCEDURE WAS DONE, BUT THE LOW RESULTS WERE STILL PRESENT. AN AUTOMATIC CLEANING EVERY 20 SAMPLES WAS INITIATED, BUT THE PROBLEM PERSISTED. THE CUVETTE WAS REPLACED AND CALIBRATION WAS PERFORMED. AFTER REPLACING THE CUVETTE, THE HEMOGLOBIN RESULTS CAME BACK TO THE NORMAL RANGE.
Additional Manufacturer Narrative
THE CONTAMINATION FOUND ON THE CUVETTES WAS PROBABLY DUE TO RESIDUAL BLOOD OR MICRO CLOTS THAT COULD NOT BE WASHED OUT. DURING THE INVESTIGATION, THERE WAS INFORMATION SUGGESTING THE QUALITY CONTROL CONCEPT WAS NOT PROPERLY APPLIED BY THE CUSTOMER. TWO CONTAMINATED CUVETTES WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION AND PRODUCED QUALITY CONTROL MEASUREMENT ALARMS WHEN TESTED. THE CUSTOMER'S QUALITY CONTROL VERIFICATION SHOULD HAVE WARNED THE CUSTOMER ABOUT THE STATE OF THE SYSTEM, IF IT WAS PROPERLY APPLIED. PROPERLY APPLYING THE QUALITY CONTROL CONCEPTS ALLOW THE CUSTOMER TO DETECT THESE CONTAMINATIONS EARLIER AND ADJUST THEIR CLEANING PROTOCOLS. NO HINTS OF AN INSTRUMENT BASED ERROR COULD BE OBSERVED. NO GENERAL CUVETTE PROBLEMS HAVE BEEN REPORTED. THE INSTRUMENT HAS BEEN REMOVED FROM THE LABORATORY.