• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  malfunction  
Manufacturer Narrative
Reporter occupation is patient/consumer.The meter was requested for investigation.Replacement product was sent.
 
Event Description
There was an allegation of a screen display issue on coaguchek xs meter serial number (b)(4).The patient stated that they could see a result of 1.6 inr on the screen but the 1 was very weak and hard to see and the 6 was lighter than normal.They also stated that when the strip icon is displayed, it is very weak.No misinterpretation of results occurred.
 
Manufacturer Narrative
Fields d9 and h3 were updated.The meter was provided for investigation.The investigation found that the display segments are shown with very little contrast in all areas.The circuit board shows no contamination that could lead to the complained error.The cause could be narrowed down to a defect in the display itself by replacing the components.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key15833843
MDR Text Key307720037
Report Number1823260-2022-03701
Device Sequence Number1
Product Code GJS
UDI-Device Identifier04015630945689
UDI-Public04015630945689
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062925
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 12/27/2022
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/21/2022
Supplement Dates Manufacturer Received12/07/2022
Supplement Dates FDA Received12/27/2022
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
-
-