COBAS B 221 6 ROCHE OMNI S6 SYSTEM
Received Dec 22, 2014 · Event occurred Dec 4, 2014
Report 1823260-2014-10340 · MDR key 4353686
Device
Generic name
Blood Gas Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03337154001
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
077 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DATE RECEIVED BY MANUFACTURER - IT HAS BEEN CONFIRMED THAT THE DATE RECEIVED BY THE MANUFACTURER IS (B)(6) 2014. THE INVOLVED PATIENT WAS NOT ADVERSELY AFFECTED. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
IT WAS DETERMINED THAT THE SENSOR WAS OLDER THAN 28 DAYS, WHICH IS OUTSIDE OF SPECIFICATIONS, THEREFORE, RESULTS FROM THE COBAS B 221 ANALYZER WERE NOT VALID.
Description of Event or Problem
ACCORDING TO THE NURSES IN THE ICU AT THIS CUSTOMER SITE, THEY HAVE HAD AN ONGOING ISSUE WITH RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WHEN RESULTS ARE COMPARED BETWEEN A COBAS B221 ANALYZER AND A COBAS B 123 ANALYZER. RESULTS ARE COMPLETELY DIFFERENT FROM ONE ANALYZER TO THE NEXT. THE CUSTOMER ONLY PROVIDED INFORMATION FOR ONE PATIENT SAMPLE TESTED FOR PH. CONTROL RECOVERY ON BOTH ANALYZERS HAS BEEN COMPARABLE. THIS MEDWATCH IS BEING FILED FOR THE COBAS B221 ANALYZER. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE REPORT ON THE COBAS B123 ANALYZER. WHEN THE AFFECTED SAMPLE WAS RUN ON THE COBAS B123 ANALYZER, THE PH RESULT WAS 7.6. THE SAMPLE WAS THEN TESTED FOR PH IMMEDIATELY AFTER ON A COBAS B221 ANALYZER, RESULTING AS 7.447. IT WAS ASKED, BUT IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).