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

Catalog Number 04625412003

Device Problems Display Difficult to Read (1181); Image Display Error/Artifact (1304)

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

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The meter was requested for investigation.

Event Description

The customer reported a display issue with coaguchek xs meter serial number (b)(4).The customer stated that not all segments are readable when performing a display check.Segments are missing in the results field that could lead to a misinterpretation of results.No misinterpretation of results was reported.

Manufacturer Narrative

The meter was returned for investigation.Corrosion was found on a battery contact on the circuit board.The meter was able to be powered on after cleaning the contact.A display check was performed and no errors were present on the display.Contamination was found in the area of the conductive rubber which may have temporarily caused the missing segments in the complaint.The root cause is contamination caused by improper customer handling or maintenance.Medwatch fields d9 and h3 have been updated.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.The customer confirmed that the battery contacts are oxidized.It is assumed that the internal contamination of the meter initiated an internal short circuit, which allows visible segments during display check but the segments are displayed in a weaker contrast.

• 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: 15874284
• MDR Text Key: 307698817
• Report Number: 1823260-2022-03783
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

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: 04625412003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 01/09/2023; 01/20/2023
• Supplement Dates FDA Received: 02/02/2023; 02/15/2023
• 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
• Patient Sex: Female