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

Catalog Number 04912551190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).The full facility name was provided as(b)(4).

Event Description

The customer stated that they received erroneous results for two samples from the same patient tested for d-di tina-quant d-dimer gen.2 (ddi) on two different cobas 6000 c (501) module - c501 analyzers.Erroneous results were reported outside of the laboratory.The first sample was initially tested on the c501 a analyzer, resulting as 757 ug feu/l.Three hours later, a second sample was collected from the patient and tested on the c501 a analyzer, resulting as 162 ug feu/l.The physician asked for repeat testing to be performed.Both samples were repeated on a second c501 (c501 b) analyzer, with the first sample resulting as 357 ug feu/l and the second sample resulting as 118 ug feu/l.Both samples were then repeated on both systems.When tested on the c501 a analyzer, the first sample resulted as 464 ug feu/l and the second sample resulted as 119 ug feu/l.When tested on the c501 b analyzer, the first sample resulted as 357 ug feu/l and the second sample resulted as 118 ug feu/l.On (b)(6) 2016, precision testing was performed and then both samples were repeated again on both systems.When tested on the c501 a analyzer, the first sample resulted as 779 ug feu/l and the second sample resulted as 134 ug feu/l.When tested on the c501 b analyzer, the first sample resulted as 729 ug feu/l and the second sample resulted as 152 ug feu/l.The patient was not adversely affected.The serial numbers of the c501 analyzers were requested but not provided.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.No sample from the patient was available for investigation.Calibration traces for the first c501 analyzer showed frequent calibration failures.Maintenance was up to date, controls were ok, no alarm messages were issued, and precision testing was ok.Assuming that maintenance, hardware, and handling of materials were ok, the issue may have been caused by unique sample characteristics, including gel particulates, fibrin, foam, clots, oil droplets, as well as interfering factors within the sample.

• 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: 6263223
• MDR Text Key: 65246772
• Report Number: 1823260-2017-00107
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• 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: 152134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• 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