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

Model Number XS PST

Device Problem Image Display Error/Artifact (1304)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

We received an allegation of a display issue on a coaguchek xs meter.The customer stated that after powering the meter off, they powered it back on and saw a "4" on the screen.The customer stated that the "4" they saw was in the far right position of the results field and that they did not see the word "error" on the screen.The customer stated that there was no strip in the meter when this occurred.It was reported that there were no units of measure next to the "4" and that the "4" stayed on the screen until the meter was powered off and back on again.A display check was performed and it was confirmed that no segments were missing.The display issue did not lead to a misinterpretation of results.

Manufacturer Narrative

Occupation is patient/consumer the meter was requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.

Manufacturer Narrative

The meter was provided for investigation.The investigation found that the display did not show any noticeable errors during the examination and the circuit board showed no contamination.The alleged error 4 when the meter is turned on is not entered in the meter error log.The investigation did 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15575080
• MDR Text Key: 301732429
• Report Number: 1823260-2022-03110
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2022
• 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
• Patient Sex: Female