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

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they received an erroneous roche cardiac d-dimer (ddi) result for one patient sample tested on a cobas h 232 analyzer.The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states.The sample initially resulted as 0.33 ug/ml when tested on the cobas h 232 analyzer.The initial result was reported outside of the laboratory.The sample was sent to an external laboratory where ddi was repeated using the sysmex cs-5100, innovance d-dimer test on (b)(6) 2016.The repeat result from the sysmex test was 705 ug/l.The patient was not adversely affected.The cobas h 232 analyzer serial number (b)(4).

Manufacturer Narrative

The customer provided the test strip material and a sample from the patient for investigation.The results from investigations performed with the customer test strip material and retention material fulfilled requirements.No failures or irregularities were seen during the investigation.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN AND 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: 5450686
• MDR Text Key: 38655738
• Report Number: 1823260-2016-00182
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K033491
• 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: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 04877802190
• Device Lot Number: 282458-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• 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