MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PROF KIT; PROTHROMBIN TIME MONITOR

Catalog Number 04837975001

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

There was an allegation of a display issue with the coaguchek xs meter.The reporter stated that there were faded segments in the results field.A display check was performed and it was noted that the greater than symbol, the left and right sides of the top circle of the "8's", and the "%q" were all faded.The meter memory was checked and the "mem" and "inr" were faded along with the "1" of the "1.6" result on the screen.It was confirmed that there was no misinterpretation of results due to the display issue.

Manufacturer Narrative

The meter was requested for investigation.A replacement product was sent.The investigation is ongoing.

Manufacturer Narrative

The investigation determined that the event was caused by contamination of the contacts due to improper handling or maintenance.Product labeling states: "- if you store the meter for a period of time, remove the batteries.-use the meter at a relative humidity of less than 85%, without condensation." "please follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Clean the meter only when contaminated with blood.Do not use sprays of any sort.Ensure that swab or cloth is only damp, not wet.".

• Brand Name: COAGUCHEK XS PROF KIT
• 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 Key: 17239824
• MDR Text Key: 318222127
• Report Number: 1823260-2023-02135
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702126107
• UDI-Public: 00365702126107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/30/2023
• 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 Number: 1