MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT ANTISTREPTOLYSIN O; ANTISTREPTOLYSIN - STREPTOLYSIN O REAGENT

Catalog Number	08105472190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tina-quant antistreptolysin o results from one patient sample tested on the cobas c 503 analytical unit.On (b)(6) 2025: the initial result of the undiluted patient sample was 295 or 296 iu/ml.The first repeat result of the undiluted patient sample was 295 iu/ml.On (b)(6) 2025: the second repeat result of the undiluted patient sample was 308 iu/ml.The third repeat result of the undiluted patient sample was 310 iu/ml.The fourth repeat result from the first module, with the patient sample at 1:5 dilution manually ordered, was 6504 iu/ml with an invalidating data flag.The fifth repeat result from the first module, with the patient sample at 1:5 dilution manually ordered, was 7895 iu/ml with an invalidating data flag.The sixth repeat result from the second module, with he patient sample at 1:3 dilution manually ordered, was 3445 iu/ml with an invalidating data flag.The seventh repeat result from the second module, with the patient sample at 1:3 dilution manually ordered, was 7926 iu/ml with an invalidating data flag.The eighth repeat result from a partner laboratory's c 702 module, with the patient sample undiluted, was 257 iu/ml with an invalidating data flag.The ninth repeat result from the partner laboratory's c 702 module with the patient sample on auto rerun at decreased mode was 7301 iu/ml with an invalidating data flag.The tenth repeat result from a partner laboratory's c 702 module with the patient sample at a 1:50 manually ordered dilution was 16445 iu/ml.The physician questioned the initial result, as the patient's previous results were >6000 iu/ml.
Additional Manufacturer Narrative
Medwatch fields a2 age number and a2 age units were updated.Abnormal aspiration errors were also noted in the alarm trace.Per product labeling, "high-dose hook effect: no false result occurs up to an antistreptolysin o activity of 4000 iu/ml." the investigation determined that the root cause is related to a high dose hook effect, which is consistent with the concentration in the sample being extremely high.

• Brand Name: TINA-QUANT ANTISTREPTOLYSIN O
• Common Device Name: ANTISTREPTOLYSIN - STREPTOLYSIN O REAGENT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22307034
• Report Number: 1823260-2025-01911
• Device Sequence Number: 7997758
• Product Code: GTQ
• UDI-Device Identifier: 07613336133545
• UDI-Public: 07613336133545
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 08105472190
• Device Lot Number: 85063601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Unknown