MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT 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 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested for tina-quant d-dimer (d-di).The erroneous results were reported outside of the laboratory.The initial d-di result was 5923 ng/ml on a c501 analyzer.This result was reported outside of the laboratory.The patient went to a different laboratory that same day where the d-di result from an abbott architect analyzer was <250 ng/ml.The specific result was not provided.Based on both of these results the patient was treated with fragmin.No adverse event has been reported due to this treatment.It was noted that the patient was fine after 2-3 days and her pregnancy was not jeopardized.The patient complained about the initial result on (b)(6) 2015.The initial sample was repeated twice: once from a vacutainer and once from a cup.The repeat results were 5697 ng/ml and 5669 ng/ml.An aliquot of the initial sample was also sent to a different laboratory and the result was 242.1 ng/ml.A new sample was obtained on (b)(6) 2015 and the patient was tested on the c501 analyzer again.The initial result from this 2nd sample was 5792 ng/ml.Dilutions were performed on this sample on (b)(6) 2015 where a 1:2 dilution was 1116 ng/ml, a 1:4 dilution was 260 ng/ml and a 1:8 dilution was 432 ng/ml.The c501 analyzer serial number was (b)(4).The customer suspects there is some kind of interference in the sample.

Manufacturer Narrative

A patient sample was submitted for investigation.During the investigation a non-specific reaction from igm was identified.This could cause erroneously high tina-quant d-dimer values.The correct tina-quant d-dimer value of the patient sample is believed to be 0.38 ug feu/ml based on the converted values after absorption with an anti-igm antibody.This interference is the most likely root cause of the discrepant results.This interference is covered in product labeling.

• Brand Name: TINA-QUANT D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5148355
• MDR Text Key: 28253326
• Report Number: 1823260-2015-04333
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SR
• 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: Health Professional
• Type of Report: Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2016
• Device Catalogue Number: 04912551190
• Device Lot Number: 614565
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/24/2015
• 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
• Patient Age: 038 YR