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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
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2022
Event Type  malfunction  
Event Description
The customer complained of a display issue with coaguchek vantus meter serial number (b)(4).The customer states the meter display gets dim after powering on.No segments are missing from the results field but the results field is difficult to read due to the screen being dim.No misinterpretation of results was reported.
 
Manufacturer Narrative
Occupation is patient/consumer the meter has been requested for investigation.The investigation is ongoing.
 
Manufacturer Narrative
The meter was returned for investigation.The returned meter was powered on and it was confirmed the backlight was very dim.The assembly and contacting of the display are correct.No customer mishandling or user error was observed.The display was replaced with a retention display and the meter performed as intended.The original meter display was determined to be defective.Medwatch fields d9 and h3 have been updated.
 
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Brand Name
COAGUCHEK VANTUS
Type of Device
PROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key15969561
MDR Text Key308462655
Report Number1823260-2022-03992
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702700499
UDI-Public00365702700499
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/09/2023
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 Model NumberCOAGUCHEK INRANGE
Device Catalogue Number07729952160
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/21/2022
Initial Date FDA Received12/13/2022
Supplement Dates Manufacturer Received02/09/2023
Supplement Dates FDA Received03/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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