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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 or Visual Feedback Problem (1184); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2018
Event Type  Malfunction  
Manufacturer Narrative

Unique identifier (udi)# (b)(4).

 
Event Description

The customer's wife complained of a display issue with coaguchek xs meter serial number (b)(4). The customer's wife stated that they changed the batteries, but the display issue was not resolved. A display check was performed and there were segments missing in the results field. The display appears as three horizontal lines on the top and a backward l instead of the expected "888" display result. There was no allegation that an adverse event occurred. The device was requested for investigation. The investigation is ongoing.

 
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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 Key7544601
MDR Text Key109643911
Report Number1823260-2018-01600
Device Sequence Number1
Product Code GJS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator PATIENT FAMILY MEMBER OR FRIEND
Device Catalogue Number03666794001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/06/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
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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