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 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The country of origin is (b)(6).The investigation is ongoing.

Event Description

The initial reporter complained of questionable d-dimer gen.2 results for 1 patient sample on a cobas c 503 analyzer with an unknown serial number.The customer obtained a result of ~28000 ug/l on aqt radiometer which was not trusted.On (b)(6) 2021 the customer received an initial result of 8431 ug/l and repeat results of 8430ug/l (non-diluted) and 38907 ug/l (1:5 dilution).The results were reported outside the laboratory.

Manufacturer Narrative

Due to insufficient information and sample quality, further internal investigations are not possible.The customer sent samples for investigation, but the samples were not frozen and had been thawed for about a week, making them unacceptable for testing.In general, increased d-dimer results are a common finding for patients with covid-19 infection; in some cases, a lower recovery may occur due to the presence of d-fragments.The lower, but pathological, results in comparison to the competitor analyzer could have been caused by d-fragments in the sample as the results of the 1:5 dilution show an increase from 8430 ¿g/l in the normal mode up to 38907 ¿g/l in the dilution.The investigation did not identify a product problem.The cause of the event could not be determined was consistent with an interferent.

• 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: 11746304
• MDR Text Key: 248429007
• Report Number: 1823260-2021-01285
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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: 517644
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1