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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 04625412019
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2023
Event Type  malfunction  
Event Description
It was reported there was an issue with the display of a coaguchek xs meter.The customer stated that the screen of the device was dim.The numbers from the result field of the display could not be read.The customer stated that when the device was powered on, it kept returning to the time and date setting.The customer was unable to read the screen, so he could not tell if the correct date was being entered.The customer stated that the batteries were recently replaced.
 
Manufacturer Narrative
Medwatch field e3.Occupation - the occupation is patient/consumer.
 
Manufacturer Narrative
The product was not returned for investigation.The investigation could not identify a product problem.The cause of the event 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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key17552033
MDR Text Key321724066
Report Number1823260-2023-02645
Device Sequence Number1
Product Code GJS
Combination Product (y/n)Y
Reporter Country CodeTU
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/20/2023
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 Catalogue Number04625412019
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/19/2023
Initial Date FDA Received08/15/2023
Supplement Dates Manufacturer Received09/20/2023
Supplement Dates FDA Received09/20/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient SexMale
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