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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 08/07/2018
Event Type  Malfunction  
Event Description

The customer stated the numbers were flickering on the display of her meter. While troubleshooting with customer support, a display check was performed and no segments of the display were missing. The customer stated that for the three 8s that are supposed to be displayed during the display check, only one of the 8s were flickering. The customer stated her meter result of 1. 4 inr was flickering. She also stated the result changed from 1. 4 inr to 0 inr back to 1. 4 inr. This issue could affect the interpretation of patient results. There was no allegation of an adverse event or of any results being incorrectly interpreted. The suspect meter was requested to be returned for further 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 Key7836770
Report Number1823260-2018-02932
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2018
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 Manufacturer11/15/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
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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