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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
Model Number XS PST
Device Problems Display; Display or Visual Feedback Problem; Device Subassembly
Event Date 11/30/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer stated that the coaguchek xs meter (b)(4) did not show complete segments in the three large "8s" seen in the results display. All of the top segments were missing, as well as some missing on the bottom and right sides. There was no physical damage evident with the display screen or meter. The meter was no dropped prior to the display issue. There was no incorrectly displayed result received or reported. The customer's meter was requested for investigation. The meter was returned for investigation. Upon initial investigation, a display check was performed on the meter and missing segments in the result field could be confirmed. No adverse events were alleged.

 
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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 Key7117098
Report Number1823260-2017-02927
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberXS PST
Device Catalogue Number03666794001
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
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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