• 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 10/28/2022
Event Type  malfunction  
Event Description
There was an allegation of intermittent display issues with a coaguchek xs meter.The customer stated the batteries may have been installed incorrectly.When the meter was powered on the results field displayed "88.1." instead of the correct display of "88.8." upon completion of a display check, the results field correctly displayed "88.8." the meter settings were reviewed and the meter was turned off.When the meter was powered back on the results field displayed "18.8." the meter memory was reviewed and the results field was complete.After the initial point of contact, the customer replaced the batteries and requested assistance resetting the meter.The reporter stated there were no display issues with this set of batteries.Upon completion of a display check, the results field correctly displayed "88.8." there were no missing segments.The meter memory was reviewed and there were no missing segments.The meter was powered on and "88.8" appeared correctly.The meter was powered on by inserting a test strip and the code number displayed correctly with no missing segments.
 
Manufacturer Narrative
Reporter occupation is patient/consumer.The meter was requested for investigation.The investigation is ongoing.
 
Manufacturer Narrative
The meter was received for investigation.The circuit board was contaminated by penetrated liquid.This contamination affects the conductive rubber contacts on the circuit board.Upon turning on the meter, missing segments were observed.Missing segments were shown clearly when confirming the code number, the countdown for blood application, and the meter result.No plausible results were displayed.The investigation determined the root cause of the issue was contamination of the contacts due to improper handling or maintenance by the customer.
 
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 Key15837661
MDR Text Key307723362
Report Number1823260-2022-03715
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 12/12/2022
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
Date Returned to Manufacturer11/08/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/28/2022
Initial Date FDA Received11/21/2022
Supplement Dates Manufacturer Received11/22/2022
Supplement Dates FDA Received12/12/2022
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
Patient SexFemale
-
-