MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem Cardiac Enzyme Elevation (1838)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received a questionable d-dimer gen.2 result for one patient with cobas integra 400 plus serial number (b)(4).The initial result at 10:34 was 2641.1 ng/ml.This result was reported outside the laboratory.The patient questioned the result due to her clinical history and another sample (sample 2) was collected.On (b)(6) 2021, sample 2 was tested at another facility on a cobas 6000 at 11:58 with a result of 1594 ng/ml.The initial sample was tested on the cobas 6000 at 14:28 with a result of 1481 ng/ml.The initial sample was repeated on the integra 400 plus at 18:24 with a result of 2708.78 ng/ml.

Manufacturer Narrative

The investigation determined the event was consistent with an interference due to d fragment molecules in samples from covid-19 patients.This interference may affect results differently depending on the instrument platform.The investigation did not identify a product problem.The product performs within specification.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11777587
• MDR Text Key: 251849080
• Report Number: 1823260-2021-01357
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04912551190
• Device Lot Number: 51964501
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1