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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PLUS; PROTHROMBIN TIME MONITOR
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ROCHE DIAGNOSTICS COAGUCHEK XS PLUS; PROTHROMBIN TIME MONITOR Back to Search Results
Catalog Number 05021537001
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
The meter has been requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.
 
Event Description
The initial reporter had an issue with the display of the coaguchek xs meter.The reporter stated the meter has a partial display.Reporter stated the partial display could lead to a misinterpretation of results.
 
Manufacturer Narrative
The reporter's meter was returned for investigation.The meter display foil was checked and did not show any damage or strong pressure marks.The device was disassembled for further investigations of the electronic parts.The visual inspection of the electronic parts showed no abnormalities, no contamination was found.The device showed no error.The claimed errors cannot be reproduced.Medwatch fields d10 and h3 have been updated.
 
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Brand Name
COAGUCHEK XS PLUS
Type of Device
PROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9575032
MDR Text Key217642008
Report Number1823260-2020-00114
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 health professional,user faci
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05021537001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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