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

Model Number COAGUCHEK XS PST

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

There was an allegation of a display issue with a coaguchek xs meter.The customer alleged the meter was missing segments in the results field.There was no misinterpretation of results from the device.

Manufacturer Narrative

The meter was requested for investigation.The customer also reported they received error 4 and error 8 messages when attempting the test.Error 4 indicates the test strip is unusable or the sample was applied too early.Error 8 indicates an error occurred during the internal diagnostic test.Error 4 and error 8 were observed in the error code report from the returned meter.A display check was performed and several missing segments were observed.The investigation is ongoing.

Manufacturer Narrative

The investigation of the returned meter shows that the battery compartment and circuit board is contaminated by a leaked battery, which affects and interrupts the conductive rubber contacts.The contamination of the circuit board can temporarily lead to the errors mentioned.The root cause of the missing segments is contamination of the contacts due to improper handling or maintenance.Medwatch field d9 has been updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17329348
• MDR Text Key: 319492252
• Report Number: 1823260-2023-02259
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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 Model Number: COAGUCHEK XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/14/2023
• 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