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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS COAGUCHEK XS PLUS PROTHROMBIN TIME MONITOR Back to Search Results
Catalog Number 05021537001
Device Problem Erratic or Intermittent Display
Event Date 11/19/2018
Event Type  Malfunction  
Event Description

The customer had an issue with the display of the coaguchek xs meter that could impact the interpretation of test results. The nurse stated the display was missing pixels in the result field of the display. The nurse performed a display test and confirmed the pixels were damaged. There was no allegation of an adverse event. The suspect product was requested to be returned for investigation. Replacement product was sent.

 
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Brand NameCOAGUCHEK XS PLUS
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 Key8138787
Report Number1823260-2018-04685
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number05021537001
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
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

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