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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of high results not matching the clinical picture for 1 patient sample tested for tina-quant d-dimer gen.2 (d-di2) on a cobas integra 400 plus.On (b)(6) 2019 the d-di2 result from the integra 400 plus was 4663 ng/ml.On (b)(6) 2019 the d-di2 result from the integra 400 plus was 4047 ng/ml.On (b)(6) 2019 the d-di2 result from the integra 400 plus was 4994 ng/ml.The high results were reported outside of the laboratory.The result from a coagulation analyzer was 200 ng feu/ml (100 ng/ml).It is not clear if this result was from one of the samples tested on the integra 400 plus or if this was for a new sample.The low result from the coagulation analyzer was believed to be correct.The integra® 400 plus analyzer serial number was (b)(4).

Manufacturer Narrative

It was clarified that there were no adverse event due to the integra results.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: 9314416
• MDR Text Key: 199314572
• Report Number: 1823260-2019-04045
• 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: 12/26/2019

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: 04912551190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR