MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT COMPLEMENT C3C TEST SYSTEM; COMPLEMENT C3 TEST

Catalog Number 08105537190

Device Problems High Test Results (2457); Output Problem (3005)

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

Event Date 01/20/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable c3c-2 tina-quant complement c3c ver.2 and c4-2 tina-quant complement c4 ver.2 results for 1 patient sample on a cobas pro c 503 analytical unit.This medwatch will cover c3c.Refer to medwatch with a1 patient identifier (b)(6) for information on the c4 results.On (b)(6) 2024, the initial c3c result was 62.6 mg/dl.The doctor questioned the results and the sample was repeated.On (b)(6) 2024, the sample was repeated and the repeat c3c result was 104 mg/dl.

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The investigation is ongoing.

Manufacturer Narrative

The alarm trace showed 36 abnormal aspiration alarms.Blood was visible in the gel layer of the sample.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: TINA-QUANT COMPLEMENT C3C TEST SYSTEM
• Type of Device: COMPLEMENT C3 TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS AUTOMATION SOLUTIONS GMBH; maybachstrasse 30; waiblingen (baden-wurttemberg) 71332 ; GM 71332
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18760036
• MDR Text Key: 336869016
• Report Number: 1823260-2024-00524
• Device Sequence Number: 1
• Product Code: CZW
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: K012361
• 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: 04/08/2024

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: 08105537190
• Device Lot Number: 64986301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female