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

Catalog Number 03666794001

Device Problem Image Display Error/Artifact (1304)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

It was reported that there was an issue with the display of coaguchek xs meter serial number (b)(4).Segments were missing from the results field of the display.A display check was performed and in the results field, it displayed "000" on the bottom part of the screen, rather than a complete "888".In place of the top part of the "888" are 3 horizonal lines.More than one segment of the display was missing.The meter has not been dropped or broken.

Manufacturer Narrative

The customer's meter was requested for investigation and a replacement was sent to the customer.Occupation - the occupation is patient/consumer.

Manufacturer Narrative

The meter was returned for investigation.When examining the display, segments are shown with a weak contrast.The battery contacts in the battery compartment and circuit board were contaminated by a liquid (leaked battery) which has penetrated/corroded the solder contacts.The contamination would be caused by a mishandling of the device.

• 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 Key: 15294074
• MDR Text Key: 302021060
• Report Number: 1823260-2022-02558
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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 Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/13/2022
• 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 Number: 1