MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2; IMMUNOGLOBULIN A

Catalog Number	08057885190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with tina-quant iga gen.2 on a cobas pure c 303 analytical unit.The sample initially resulted in an iga value of 2.0 mg/dl.The sample was repeated on a second analyzer, resulting in a value of 29.04 mg/dl.
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
No questionable results were reported outside of the laboratory.All results were accompanied by data flags since system reagents on board the analyzer were expired.The investigation determined the issue was due to a user error since system reagents exceeded onboard stability at the time of the event.

• Brand Name: TINA-QUANT IGA GEN.2
• Common Device Name: IMMUNOGLOBULIN A
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20843740
• Report Number: 1823260-2024-03514
• Device Sequence Number: 18152630
• Product Code: CZP
• UDI-Device Identifier: 07613336121313
• UDI-Public: 07613336121313
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K040435
• 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): 12/13/2024

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 Catalogue Number: 08057885190
• Device Lot Number: ASKU
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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: 12 MO
• Patient Sex: Unknown