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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR Back to Search Results
Catalog Number 03666794001
Device Problem Erratic or Intermittent Display
Event Date 05/17/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer complained of missing segments in the results field of the coaguchek xs meter that may impact the interpretation of results. The customer stated when he inserted the test strip the meter beeped but only a "spot' was flashing on the display. He pressed the power button and had one spot flashing. The customer performed a display check and could not see any icons or digits. He could only see 5 dashes across the middle of the display. There was no allegation of an adverse event. The suspect product was requested to be returned for investigation.

 
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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 Key7572639
Report Number1823260-2018-01753
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number03666794001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
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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