MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DI TINA-QUANT D-DIMER GEN. 2; FIBRIN SPLIT PRODUCTS

Catalog Number 07429410190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient sample tested with d-di tina-quant d-dimer gen.2 on a cobas t 511 coagulation analyzer.No incorrect values were reported outside of the laboratory.The cobas t 511 coagulation analyzer is not released for distribution in the united states, nor is it like or similar to a product released for distribution in the united states.The sample initially resulted with a d-dimer value of 19.2 ug/ml when tested on the t 511 analyzer.The sample was repeated on the t 511 analyzer, resulting with a value of 19.1 ug/ml.The sample was repeated a second time on the t 511 analyzer, resulting with a value of > 9.46 ug/ml accompanied by a data flag.The sample was repeated a third time of the t 511 analyzer at a reduced sample volume, resulting with a value of 19.1 ug/ml.The same sample was also tested twice on a cobas t 411 coagulation analyzer, resulting with values of 5.41 ug/ml and 5.30 ug/ml.No adverse events were alleged to have occurred with the patient.The serial number of the t 511 analyzer is (b)(4).

Manufacturer Narrative

Qc recovery on the t511 was good.The qc recovery for the t411 was not acceptable.Samples could not be provided for further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: D-DI TINA-QUANT D-DIMER GEN. 2
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8727653
• MDR Text Key: 149092098
• Report Number: 1823260-2019-02287
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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: 07429410190
• Device Lot Number: 367948
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1