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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for d-di tina-quant d-dimer gen.2 (d-dimer) on a cobas integra 400 plus (i400+).The erroneous results were reported outside of the laboratory.On (b)(6) 2017, the patient had a d-dimer result of 2755 ng/ml.On (b)(6) -2017, the patient had a d-dimer result of 2592 ng/ml.On (b)(6) -2017, the patient had a d-dimer result of 2565 ng/ml.On (b)(6) -2017, the patient had a d-dimer result of 2148 ng/ml.The complained sample was initially tested on an acl analyzer on (b)(6) 2017, resulting with a d-dimer value of 0.23 ug/ml.An aliquot from the same sample was tested on the i400+ on (b)(6) 2017, resulting as 2020 ng/ml.A second aliquot from the same sample was tested on a second i400+ in a second laboratory, resulting as 2029 ng/ml.A third aliquot from the same sample was tested on a star evolution analyzer, resulting as 320 ng/ml.On (b)(6) 2017, a second sample was collected from the patient and measured twice on the i400+ analyzer, resulting as 2132 ng/ml and 2157 ng/ml.This sample had an igg result of 10.98 g/l and an igm result of 5.44 g/l.No adverse events were alleged to have occurred with the patient.The i400+ analyzer used at the customer site was 402443.The serial number of the i400+ analyzer used the second site was asked for, but not provided.

Manufacturer Narrative

Medwatch field has been updated.3 samples from the patient were provided for investigation.The customer's results were duplicated.A high concentration of igm was also confirmed.The d-dimer results of the diluted samples are similar to results from the undiluted samples.The patient has a high igm, pointing to high concentrations of immunoglobulins and potentially gammopathy.The likely root cause of the issue is interference due to gammopathy.According to product labeling, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.Certain immunoglobulins can cause a non-specific agglutination leading to falsely high results.Based on calibration and quality control data, a general reagent issue can be excluded.

Manufacturer Narrative

The patient was treated with clexane based on high d-dimer results from the i400+ analyzer.No adverse events were alleged to have occurred with the patient.A precision check was performed on the analyzer.It was confirmed that only one patient was affected.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6954042
• MDR Text Key: 90556919
• Report Number: 1823260-2017-02336
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2017

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 04912551190
• Device Lot Number: 23293201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 10/01/2017; 10/01/2017
• Supplement Dates FDA Received: 10/31/2017; 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1