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

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.

• 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 Key: 17552033
• MDR Text Key: 321724066
• Report Number: 1823260-2023-02645
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: TU
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• 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 Number: 04625412019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male