TINA-QUANT ANTISTREPTOLYSIN O
Received Apr 14, 2025 · Event occurred Mar 20, 2025
Report 1823260-2025-01121 · MDR key 21833077
Device
Generic name
Antistreptolysin - Streptolysin O Reagent
Manufacturer
Roche DiagnosticsCatalog number
04489403190
Lot number
82332701
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 4000 C311 STAND ALONE SYSTEM IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT ANTISTREPTOLYSIN O ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT FROM THE ANALYZER WAS 397 IU/ML, AND WAS CONFIRMED BY RERUNS. THE FIRST REPEAT RESULT FROM ANOTHER LABORATORY'S POLYMERASE CHAIN REACTION (PCR) ASSAY WAS 0.41 MG/L. THE SECOND REPEAT RESULT FROM ANOTHER LABORATORY'S ANALYZER WITH A SIMILAR LABORATORY METHOD TO THE REPORTED ASSAY WAS 276 U/L. THE INITIAL AND SECOND REPEAT RESULTS HAD THE SAME CLINICAL INTERPRETATION.
Additional Manufacturer Narrative
THE CUSTOMER RECEIVED A NEW QUESTIONABLE TINA-QUANT ANTISTREPTOLYSIN O ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 622 U/L. THE REPEAT RESULT FROM AN EXTERNAL LABORATORY WAS 455 U/L. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND DID NOT FIND ANY ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM BASED ON THE INFORMATION PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
ON THE FIELD SERVICE ENGINEER'S SERVICE VISIT, HE ALSO REPLACED THE SAMPLE PROBE AS A PROACTIVE MEASURE AND CALIBRATED THE WASH STATION.