ELECSYS BRAHMS PCT
Received Feb 28, 2024 · Event occurred Feb 7, 2024
Report 1823260-2024-00570 · MDR key 18796437
Device
Generic name
Procalcitonin Assay
Manufacturer
Roche DiagnosticsCatalog number
09318712190
Lot number
71272400
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONFIRMED THAT THE ISSUE DID NOT OCCUR WITH THE ELECSYS CALCITONIN. THE CORRECT REAGENT USED IS (B)(6) PCT. THE QUESTIONABLE RESULTS WERE PROCALCITONIN RESULTS. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.
Additional Manufacturer Narrative
D4 EXPIRATION DATE WAS UPDATED. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON THE CALIBRATION AND QC DATA, THERE WAS NO EVIDENCE OF A REAGENT OR INSTRUMENT PROBLEM.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CALCITONIN ON A COBAS 6000 E601 MODULE. A SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2024 RESULTED IN A CALCITONIN VALUE OF 1.6 PG/ML. A SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2024 RESULTED IN A CALCITONIN VALUE OF 12 PG/ML. THIS VALUE WAS REPRODUCED WHEN THE SAMPLE WAS REPEATED. THE CUSTOMER ALLEGES THE VALUE WAS ABNORMALLY HIGH AND SUSPECTS THE SAMPLE MAY CONTAIN AN INTERFERING FACTOR AGAINST A COMPONENT OF THE CALCITONIN ASSAY. A SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2024 RESULTED IN A CALCITONIN VALUE OF 6.0 PG/ML AND IT REPEATED AS 6.2 PG/ML.