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

Catalog Number 04912551190

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable d-dimer results for 2 patient samples on a cobas integra 400 plus module serial number, (b)(4).Both of the samples were from the same patient.Sample 1: the initial result was 7.28 g feu/ml.The customer performed a 3-fold dilution and repeated the test.The diluted result was 16.27 g feu/ml.The customer repeated the sample on a cobas c501 module and the result was 8.50 g feu/ml.This result was reported to the patient's doctor.This was the only result reported outside of the laboratory.On (b)(6) 2020 the customer diluted the sample and the result was 18.19 g feu/ml.Sample 2: on (b)(6) 2020 a new sample was taken from the same patient.The initial result was 8.72 g feu/ml (with a data flag).The diluted result was 17.69 g feu/ml.The sample was repeated on the cobas c501 module and the initial result was 9.38 g feu/ml (with a data flag).The diluted result was 17.69 g feu/ml.The serial number of the cobas c501 module is unknown.

Manufacturer Narrative

Section b7 and the patient's medication list section were updated.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling: in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.In rare cases (less than 1 reported case per 100000 tests) certain immunoglobulins can cause a non-specific agglutination leading to falsely high results.

• 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: 10929444
• MDR Text Key: 219170626
• Report Number: 1823260-2020-03054
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• 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: 49702801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AVEDOL.; BIOTRAXON.; CLEXANE.; DEXAVEN.; PIRAMIL.; TRIFAS.