MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER GEN.2; FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY

Model Number D-DIMER G2

Device Problem Low Test Results (2458)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Medwatch field udi number = (b)(4).

Event Description

The initial reporter stated they received discrepant results for 24 patient samples tested with the d-di tina-quant d-dimer gen.2 assay on a cobas pro c 503 analyzer.The results measured on the c 503 analyzer were lower when compared to values obtained using the biomerieux mini vidas d-dimer method.No incorrect results were reported outside of the laboratory.Refer to the attachment for all patient data.The serial number of the c 503 analyzer is (b)(4).

Manufacturer Narrative

The investigation could not identify a product problem.The difference in values between the roche d-dimer reagent and the competitor reagent is most likely due to the different specificity of the antibody used or other test characteristics.D-dimer is not a standardized analyte and results generated using different d-dimer assays are not necessarily identical due to factors such as (but not limited to): reactivity/specificity of different antibodies.Epitope expression during fibrin formation and degradation.Heterogeneity of the fibrin degradation products in plasma.Calibrator material.Variation in optical detection ability between different instruments.Assay formats (latex bead size and required wavelengths).Interference by other analytes (e.G.Rheumatoid factor , mouse monoclonal antibodies).

• Brand Name: D-DIMER GEN.2
• Type of Device: FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11517423
• MDR Text Key: 266064354
• Report Number: 1823260-2021-00852
• 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: 04/08/2021

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 Expiration Date: 11/30/2021
• Device Model Number: D-DIMER G2
• Device Catalogue Number: 08105626190
• Device Lot Number: 51764401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1