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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.
 
Manufacturer Narrative
The customer's meter was received for investigation.The circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated by liquid which has penetrated and/or corroded the solders contacts.
 
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Brand Name
COAGUCHEK ® XS SYSTEM
Type of Device
PROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7544601
MDR Text Key109643911
Report Number1823260-2018-01600
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received05/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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