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

Catalog Number	03666794001
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e3 - occupation: patient/consumer.The meter was requested for investigation.A replacement meter was sent to the customer.
Event or Problem Description
We received an allegation of a display issue with a coaguchek meter.The reporter stated that the meter had been in storage for a couple of months.The reporter installed new batteries and the meter would power on but with only a partial display.A display check and meter memory check were performed and the results field was only partially visible.
Additional Manufacturer Narrative
The meter was received for investigation.The investigation determined that the event was caused by contamination of the contacts due to improper handling or maintenance.Product labeling states: "operating conditions.- if you store the meter for a period of time, remove the batteries.-use the meter at a relative humidity of less than 85%, without condensation." "please follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Wipe away residual moisture and fluids after cleaning the housing.Do not use sprays of any sort.Ensure that swab or cloth is only damp, not wet.".

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: 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: 18436641
• Report Number: 1823260-2024-00015
• Device Sequence Number: 17880141
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown