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

Catalog Number	03507343190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant iga gen.2 (iga) results from multiple patient samples tested on the cobas 6000 c 501 (ul) v.The following are examples of discrepant results: patient sample 1 the initial result from the module was 356 mg/dl.The repeat result from another c 501 module was 169 mg/dl.The repeat result was deemed correct.Patient sample 2 the initial result from the module was 437 mg/dl.The repeat result from another c 501 module was 287 mg/dl.Patient sample 3 the initial result from the module was 348 mg/dl.The repeat result from another c 501 module was 252 mg/dl.Patient sample 4 the initial result from the module was 52 mg/dl.The repeat result from another c 501 module was 151 mg/dl.Some results had invalidating flags, prompting the patient samples to be rerun.
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c501 (ul) v is (b)(6).The field service engineer (fse) investigated the event and determined that improper reagent use caused it; the customer loaded a previously used iga reagent pack from another module into the reported module.He inspected the module and verified the gear pump pressure, rinse mechanism function, and probe positioning.The fse performed precision checks and confirmed that the module works according to specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The alarm trace had multiple abnormal probe sucking alarms on the date of the event, close to the time the patient sample was processed.This is an indication of poor sample quality.The customer loaded a previously used reagent pack from another module into the reported module.Product labeling states: "reagent volume - in case of an undetected loss of reagent, the instrument pipettes no reagent or the wrong volume of reagent.The system will calculate incorrect results.- do not use a single reagent pack for different instruments." the customer did not report any other issues after the service.The investigation determined that the service actions resolved the issue.

• 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: 21975791
• Report Number: 1823260-2025-01406
• Device Sequence Number: 9188679
• Product Code: CZP
• UDI-Device Identifier: 04015630919680
• UDI-Public: 04015630919680
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Catalogue Number: 03507343190
• Device Lot Number: 791244
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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 Sex: Unknown