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

Catalog Number	08057885190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant iga gen.2 results for 1 patient sample on a cobas c 503 analytical unit.The initial result was 7682 mg/dl with a data flag.The sample was repeated using a decreased sample volume and the result was 7646 mg/dl with a data flag.The operator questioned the results, as they were above the assay measuring range, and the sample was repeated.On (b)(6) 2024 the repeated result with a 1:3 dilution was 24.6 mg/dl.The sample was repeated and the result was 28971 mg/dl with a data flag.The sample was repeated using a decreased sample volume and the result was 7443 mg/dl with a data flag.The sample was repeated using an increased sample volume and the result was 5.16 mg/dl.On (b)(6) 2024 the sample was repeated with a manual dilution (1:2 ratio) and the result was 8884 mg/dl with a data flag.The raw value, that was measured when using a decreased sample volume, was 3777 mg/dl.The final value when applying the dilution factor was 7554 mg/dl.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 expiration date was updated.The patient sample could possibly have a very high iga concentration.Based on the available data and the observed failure mode, there was no evidence of an instrument or a reagent issue.The investigation did not identify a product problem.

• 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: 19807374
• Report Number: 1823260-2024-02119
• Device Sequence Number: 18023824
• Product Code: CZP
• UDI-Device Identifier: 07613336121313
• UDI-Public: 07613336121313
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 08/27/2024

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 Expiration Date: 02/01/2025
• Device Catalogue Number: 08057885190
• Device Lot Number: 716674
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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 Sex: Female