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

Catalog Number 05991978190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.

Event 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. .

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
• Type of Device: 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
• MDR Text Key: 338754148
• Report Number: 1823260-2024-00906
• Device Sequence Number: 1
• Product Code: DEM
• UDI-Device Identifier: 04015630928415
• UDI-Public: 04015630928415
• Combination Product (y/n): Y
• Reporter Country Code: EI
• PMA/PMN Number: K010978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 05991978190
• Device Lot Number: 756717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1