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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 Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation is lay user/patient the meter was requested for investigation.
 
Event Description
The initial reporter complained of a display issue with a coaguchek xs meter.The customer stated the display was dim where the results are displayed.The customer stated results appeared as 7.6 inr and 7.2 inr on (b)(6) 2020.On a different day the result appeared as 6.1 inr.The results were hard to figure out and the meter had to be held a certain way to determine what the results were.No action was taken based on these results.
 
Manufacturer Narrative
Section d9 and h3 were updated.The device was returned for investigation.A display test was performed.The circuit board was tested for damage or contamination.Most parts of the display segments were displayed with a weak contrast.By replacing the conductive rubber, the issue was still present.The circuit board showed no contamination that could lead to the issue.The investigation determined the issue was due to a problem with an electrical component.
 
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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 Key10749541
MDR Text Key213679146
Report Number1823260-2020-02693
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 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
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 Manufacturer11/19/2020
Date Manufacturer Received10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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