• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR Back to Search Results
Model Number XS PLUS
Device Problems Display; Erratic or Intermittent Display
Event Date 02/19/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer complained of a display issue with coaguchek xs plus meter with an unspecified serial number. The customer alleged that the display on the meter fades out and they have trouble seeing the patient results. The customer alleges this could have the potential for staff to not see the result for a patient clearly leading to a misinterpretation of a result. The customer states when the display on the meter fades out, they start the test over and obtain a successful result; the result is displayed and interpreted correctly. The customer also stated the meter sometime turns off during testing. The customer will start the test over and the next attempt is successful; the meter stays powered on. No adverse event occurred. The device was requested for investigation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOAGUCHEK ® XS SYSTEM
Type of DevicePROTHROMBIN TIME MONITOR
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 Key7331930
Report Number1823260-2018-00775
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberXS PLUS
Device Catalogue Number04562780001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
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

-
-