MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT ALPHA-1 ANTITRYPSIN; ALPHA-1 ANTITRYPSIN TEST

Catalog Number	05991978190
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	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable aat alpha-1 anti-trypsin assay result from one patient sample tested on the cobas 8000 c702 module.The initial result from the module was 0.22 g/l with a data flag.The patient sample was then sent to another site for phenotyping.The initial result was then questioned prompting the rerun of the patient sample.The repeat result from the module was 1.56 g/l.This result was consistent with the other site's phenotyping results.The patient sample was again rerun several times and the result was consistently 1.5 g/l.The repeat result was deemed correct. .
Additional Manufacturer Narrative
Medwatch field d4 expiration date updated.The investigation reviewed the alarm trace.There were frequent "sample short" and "sample duplication error" alarms which also appeared on the date of event.This suggests inadequate preanalytic handling and/or wrong cup configuration.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TINA-QUANT ALPHA-1 ANTITRYPSIN
• Common Device Name: ALPHA-1 ANTITRYPSIN TEST
• 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: 18978771
• Report Number: 1823260-2024-00906
• Device Sequence Number: 17766756
• Product Code: DEM
• UDI-Device Identifier: 04015630928415
• UDI-Public: 04015630928415
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: K010978
• 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): 04/23/2024

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: 08/31/2025
• Device Catalogue Number: 05991978190
• Device Lot Number: 756717
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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