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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR
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ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR Back to Search Results
Model Number COAGUCHEK INRANGE
Medical Device Problem Code Display Difficult to Read (1181)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/23/2021
Type of Reportable Event Malfunction
Additional 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.Initial reporter occupation was lay user/patient.
 
Event or Problem Description
There was an allegation of a display issue with the coaguchek vantus meter.When running a test, the result appears but the customer had difficulty reading the inr on the display.The result appears as "white on white".A display test was performed and it was confirmed that all four colored screens were clearly visible.There was no actual misinterpretation of any result.
 
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Brand Name
COAGUCHEK VANTUS
Common Device Name
PROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key12168268
Report Number1823260-2021-02030
Device Sequence Number3704779
Product Code GJS
UDI-Device Identifier00365702700499
UDI-Public00365702700499
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K170960
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/14/2021
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
Operator of Device Lay User/Patient
Device Model NumberCOAGUCHEK INRANGE
Device Catalogue Number07729952160
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/23/2021
Initial Report FDA Received Date07/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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