MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT IGG CSF; IGG, ANTIGEN

Catalog Number	03507432190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc recovery data provided was acceptable.The investigation did not identify a product problem.The root cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable igg-2 tina-quant igg gen.2 results for 1 patient on a cobas 8000 cobas c 502 module.The doctor questioned the csf igg results for the patient.They claimed the results were implausible as the patient was receiving an igg substitution.The initial csf igg result was 76.8 mg/l.The sample was repeated twice and the results were 79.61 mg/l and 79.61 mg/l.A serum sample was collected at the same time as the csf sample.The initial serum igg result was 38.3 g/l and the repeat result was 39.4 g/l.
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation is ongoing.

• Brand Name: TINA-QUANT IGG CSF
• Common Device Name: IGG, ANTIGEN
• 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: 19530994
• Report Number: 1823260-2024-01763
• Device Sequence Number: 15331756
• Product Code: DEW
• UDI-Device Identifier: 04015630919710
• UDI-Public: 04015630919710
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K050113
• 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): 08/15/2024

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: 03507432190
• Device Lot Number: 771598
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AZATHIOPRINE.; KALYMIN.; PREDNISOLONE.; PRIVIGEN.
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 85 KG