Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer complained of missing segments from the display of the coaguchek xs meter.The customer stated that the display was faint.The customer changed the batteries and could not see what was on the display.The customer performed a display check and the display was partially missing segments.This issue could have impacted the interpretation of results.There was no adverse event.The customer was not able to perform a test because she could not read what was displayed on the screen.The suspect product was requested to be returned for investigation.
 
Manufacturer Narrative
The customer's meter was received for investigation.The circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated by liquid which has penetrated and/or corroded the solders contacts.
 
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
MDR Report Key7529251
MDR Text Key108751356
Report Number1823260-2018-01560
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/05/2018
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 Manufacturer06/06/2018
Initial Date Manufacturer Received 05/05/2018
Initial Date FDA Received05/21/2018
Supplement Dates Manufacturer Received05/05/2018
Supplement Dates FDA Received07/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-