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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 Problems Display; Erratic or Intermittent Display
Event Date 04/13/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer complained that she was receiving an error message and had issues with the display on their coaguchek xs meter. Customer stated that the results field was fading and sometimes some of the segments were missing. The customer was advised to perform a display check on the meter and the screen looked clear. The customer was advised to view the meter memory. The customer stated that the results field of the meter memory appeared to be faded in some light and that the segments could have been missing. 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 Key7505988
Report Number1823260-2018-01447
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2018
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 Manufacturer05/15/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2018
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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