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

Catalog Number 04912551190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer stated that they received erroneous results for five samples from the same patient tested with d-di tina-quant d-dimer on a cobas integra 400 plus (i400+ a) analyzer.The first sample was also tested on a cobas 6000 c (501) module and the second sample was tested on a second integra 400 plus analyzer (i400+ b).The erroneous results for the first two samples were reported outside of the laboratory.It was asked, but it is not known if erroneous results were reported outside of the laboratory for samples 3 - 5.According to the customer's internal process, samples are measured with different dilution ratios of 1:3, 1:6, and 1:12.Dilutions were carried out automatically by the analyzer.The customer stated that they also manually diluted the samples and results were similar to those of the automatic dilutions.No adverse events were alleged to have occurred with the patient.The serial number of the i400+ a analyzer is (b)(4).The serial number of the i400+ b analyzer is (b)(4).The serial number of the c 501 analyzer was asked for, but not provided.The issue did not occur with samples from other patients.Upon review of the calibration data, the correct target values were set.Quality controls showed good precision and accuracy.

Manufacturer Narrative

Multiple samples from the patient were submitted for investigation and tested with various dilutions.Using a integra 400 plus analyzer, all undiluted sample results were within the measurement range and all dilution results were higher than the reference range except for one sample that was consistently lower than the reference range.Using a cobas c501 analyzer, for two samples the undiluted results were higher than the reference range and the diluted results were comparable to the results from the integra 400 plus.As part of testing for possible interferences, iga, igg, igm and kappa, lambda were tested and all results were within the normal range.

Manufacturer Narrative

It was confirmed that the erroneous results for all samples were reported outside of the laboratory.

Manufacturer Narrative

The investigation could exclude known interferents, but could not exclude unknown interferents.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: 7817973
• MDR Text Key: 118558998
• Report Number: 1823260-2018-02860
• 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,Followup
• Report Date: 10/25/2018

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: 32475701
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 08/28/2018; 10/05/2018; 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACARD; BRILIQUE; CLEXANE
• Patient Age: 49 YR