ELECSYS BRAHMS PCT
Received Feb 28, 2023 · Event occurred Feb 2, 2023
Report 1823260-2023-00617 · MDR key 16454548
Device
Generic name
Procalcitonin Assay
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08828679190
Lot number
59498801
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS BRAHMS PCT ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A PCT VALUE OF 0.16 NG/ML. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED. THE SAMPLE WAS REPEATED RESULTING IN A PCT VALUE OF 28.9 NG/ML. A NEW SAMPLE DRAW OF THE PATIENT RESULTED IN A PCT VALUE OF 27.3 NG/ML.
Additional Manufacturer Narrative
THE LAST CALIBRATION PERFORMED ON (B)(6) 2023, AND THE QUALITY CONTROLS RESULTS DO NOT INDICATE A GENERAL REAGENT ISSUE. UPON REVIEW OF THE ALARM TRACE, NO GENERAL INSTRUMENT ISSUE WAS DETECTED. IT WAS DETERMINED THAT THE TIP OF THE SAMPLE PROBE HAD A CRYSTAL, INDICATING INADEQUATE DAILY SAMPLE PROBE MANUAL CLEANING BY THE OPERATOR. THE CRYSTALS COULD BE CONTAMINATING THE ASPIRATED SAMPLE BUT WOULD NOT CAUSE THE OBSERVED EVENT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.