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

Catalog Number 04912551190

Device Problem High Test Results (2457)

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

Event Date 04/01/2021

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 the cobas integra 400 plus serial number (b)(4).The initial result was 2.58 ug/ml.This result was reported outside of the laboratory.The sample was tested in another lab (method unknown) with a result of 0.3 ug/ml.On (b)(6) 2021, the sample was repeated on the integra 400 with a result of 3.86 ug/ml.The sample was also tested in more than one other laboratory, and all results were normal (< 0.5 ug/ml).

Manufacturer Narrative

Discrepant results for two more samples ran on an unknown date are as follows.Sample 1: the integra 400 result was 5.4 ug/ml.The manual method result was 0.4 ug/ml.Sample 2: the integra 400 result was 3.7 ug/ml.The manual method result was 0.6 ug/ml.

Manufacturer Narrative

The qc data shows imprecision.The alarm trace shows clot alarms.Further information from the customer side and the sample material were requested but not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 11737056
• MDR Text Key: 270181644
• Report Number: 1823260-2021-01269
• 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,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 04912551190
• Device Lot Number: 51964501
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1