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

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable high d-dimer gen.2 results for one patient from cobas 6000 c501 module serial number (b)(4) compared to a stago sta analyzer.On (b)(6) 2017, the result from the c501 was 3519 ng/ml and the result from the sta was 1200 ng/ml.On (b)(6) 2018, the result from the c501 was 3360 ng/ml and the result from the sta was 720 ng/ml.It was unclear if the same sample was used for both tests.The results were reported outside of the laboratory.There was no allegation of an adverse event.Calibration and qc results were inconspicuous and were in range, therefore a general issue with the reagent or instrument could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined as sample material was not available for further investigation.

• 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: 7867956
• MDR Text Key: 119950448
• Report Number: 1823260-2018-03085
• Device Sequence Number: 1
• Product Code: GHH
• UDI-Device Identifier: 04015630922956
• UDI-Public: 4015630922956
• 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
• Report Date: 09/12/2018

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/12/2018
• 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: 34 YR