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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 Difficult to Read (1181); Loss of Data (2903)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
The reporter's product was requested for investigation and replacement product was sent to the reporter.
 
Event Description
The initial reporter stated there is an issue with the software and display of coaguchek xs meter serial number (b)(4).The reporter stated he measured a value of 4.9 inr on the meter and this value was missing from the meter's result memory.The reporter also stated that the display appeared blurry.He checked the display and the "888" in the results field of the display looked blurry.The reporter could not advise if any segments were missing from the results field.The reporter was asked if the 4.9 inr result appeared to be blurry when he received the result, but he was unable to provide any information.
 
Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.
 
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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 Key10118758
MDR Text Key194002705
Report Number1823260-2020-01364
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 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Initial Date Manufacturer Received 05/15/2020
Initial Date FDA Received06/04/2020
Supplement Dates Manufacturer Received05/15/2020
Supplement Dates FDA Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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