MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CARDIAC READER D-DIMER TEST STRIP

Catalog Number 12241528196

Device Problem Low Test Results (2458)

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

Event Date 04/24/2015

Event Type  malfunction  

Event Description

The customer received a questionable cardiac d-dimer result from a cobas h232 meter.This meter is not sold in the united states.The specific date of testing was not provided.The result from the h232 meter was 1.2 ug/ml and the result from a large laboratory analyzer was 139.2 ug/dl.Clarification of the unit of measure was requested, but was not provided.Information concerning which result was reported was requested, but was not provided.There was no adverse event reported.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: CARDIAC READER D-DIMER TEST STRIP
• Type of Device: D-DIMER TEST STRIP
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4752915
• MDR Text Key: 18894600
• Report Number: 1823260-2015-03429
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/06/2015

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: 12241528196
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/06/2015
• 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
• Patient Sequence Number: 1