COBAS B 221 <6> SYSTEM

Additional Manufacturer Narrative

THE CARTRIDGE LOT NUMBERS AND THEIR EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE HEMOGLOBIN (THB) AND HEMATOCRIT RESULTS FROM FOURTEEN (14) PATIENT SAMPLES TESTED ON THE COBAS B 221 <6> SYSTEM. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES: PATIENT SAMPLE 1 ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE ANALYZER: THE INITIAL THB RESULT WAS 5.29 G/DL. THE INITIAL HEMATOCRIT RESULT WAS 17.2%. ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE FLOW CYTOMETER: THE REPEAT THB RESULT WAS 7.7 G/DL. THE REPEAT HEMATOCRIT RESULT WAS 23.7%. PATIENT SAMPLE 2: ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE ANALYZER: THE INITIAL THB RESULT WAS 4.83 G/DL. THE INITIAL HEMATOCRIT RESULT WAS 28.3%. ON (B)(6) 2025, THE FOLLOWING ARE THE RESULTS FROM THE FLOW CYTOMETER: THE REPEAT THB RESULT WAS 6.1 G/DL. THE REPEAT HEMATOCRIT RESULT WAS 17.7%. PATIENT SAMPLE 3: ON (B)(6) 2025: THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 18.6% (THE THB RESULT WAS 3.16 G/DL). THE REPEAT HEMATOCRIT RESULT FROM THE FLOW CYTOMETER WAS 10% (THE THB RESULT WAS 3.2 G/DL). PATIENT SAMPLE 4: THE INITIAL HEMATOCRIT RESULT FROM THE ANALYZER WAS 20.7% (THE THB RESULT WAS 5.14 G/DL). THE REPEAT HEMATOCRIT RESULT FROM THE FLOW CYTOMETER WAS 15.2% (THE THB RESULT WAS 4.8 G/DL). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER FOLLOWS THE GENERAL RULE THAT THE HEMATOCRIT SHOULD BE THREE TIMES THE THB RESULT, PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE FLOW CYTOMETER RESULTS WERE DEEMED BELIEVABLE.

Additional Manufacturer Narrative

DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

Additional Manufacturer Narrative

MEDWATCH FIELD D2B PROCODE UPDATED.