COBAS B 221 GLU/LAC CASSETTE

Additional Manufacturer Narrative

MEDWATCH FIELDS D4 LOT NO AND D4 EXPIRATION DATE WERE UPDATED. THE INVESTIGATION REVIEWED THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION RESULTS REMAINED STABLE AFTER RECALIBRATION DUE TO A SENSITIVITY DRIFT FAILURE. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE CUSTOMER PERFORMED TWO SAMPLE MEASUREMENTS BEFORE RUNNING THE QC OF THE REPORTED CASSETTE. PRODUCT LABELING STATES: "QUALITY CONTROL - GENERAL. FAILURE TO FOLLOW QC PROTOCOLS OR IGNORING QC RESULTS MAY LED TO INCORRECT PATIENT RESULTS, WHICH MAY ENDANGER PATIENT LIVES." "PERFORM QC TESTS ON 3 LEVELS AFTER EACH OF THESE ACTIONS: REPLACEMENT OF MSS CASSETTE, ELECTRODE, FLUID PACK, OR RINSE SOLUTION STARTUP OF THE SYSTEM. AFTER PERFORMING PROFICIENCY TESTING." " DO NOT USE THE SYSTEM FOR DIAGNOSTIC PURPOSES UNTIL QC RESULTS MATCH THEIR EXPECTED RESULTS." THE ALARM TRACE CONTAINED ABNORMAL ASPIRATION AND SAMPLE-FOAM DETECTION ALARMS. THE CUSTOMER STATED THAT THEY PERFORMED DECONTAMINATION AND WETTING PROCEDURES, WHICH RESOLVED THE ISSUE. THE FIELD SERVICE ENGINEER REPLACED A BROKEN LEVER. THE INVESTIGATION CONFIRMED THAT THE REPORTED LOT SUCCESSFULLY PASSED ALL INTERNAL MANUFACTURING AND QUALITY CONTROL SPECIFICATIONS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE COBAS B 221 <6> SYSTEM SERIAL NUMBER IS (B)(6). THE CUSTOMER STATED THAT THE QCS WERE ALSO OUT OF RANGE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE COBAS B 221 GLU/LAC CASSETTE RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS B 221 <6> SYSTEM. ONE EXAMPLE OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE WAS PROVIDED: THE INITIAL GLUCOSE RESULT FROM THE ANALYZER WAS 40 MG/DL. THE REPEAT GLUCOSE RESULT FROM ANOTHER COBAS B 221 ANALYZER WAS 65 MG/DL.