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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 Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Occupation was lay user/patient.The reporter's meter was requested to be returned for investigation.Replacement product was sent.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 that caused missing segments in the results field.The meter was put away after testing and when the customer went to test using the meter again, the meter was missing a part of the screen and appeared to have a portion of the screen that was blocked out in the results field.
 
Manufacturer Narrative
The batteries were not changed prior to the display check.The customer did not allege that she had misinterpreted any of the readings that had been received.
 
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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 Key9545131
MDR Text Key190478839
Report Number1823260-2020-00023
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 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
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? No
Date Manufacturer Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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