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	10/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about an odd display when the patient tried to test on a coaguchek xs meter.The patient's husband alleged that once he released the power button, the meter showed a flashing strip icon and < rrr sec in the results field with the time and date above it.The patient's husband stated the display issue began on 28-oct-2023 when the patient ran a test which resulted in 1.6 inr and believed to be low.The display appeared dim at that time too.Reportedly, the patient's warfarin dosage was increased based on the meter result of 1.6 inr on 28-oct-2023.The patient¿s therapeutic range was 2.0-3.0 inr.
Additional Manufacturer Narrative
Section e: the reporter is the patient's/consumer's husband.On the call, a display test was performed.The meter memory was also reviewed and it showed 1.6 inr on 28-oct-2023.The meter showed that it was coded correctly.The patient's meter was requested for investigation.The patient has apas.Product labeling states: "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician." the investigation is ongoing.
Additional Manufacturer Narrative
The meter was provided for investigation where the device data and fault memory were read out.A display test was performed and the circuit board was tested for damage or contamination.The circuit board showed contamination caused by a penetrated liquid which affected the conductive rubber contacts.Some segments were only displayed with a weak contrast.The investigation did not identify a product problem.There was a user error.The root cause was contamination of the contacts due to improper handling or maintenance.

• 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: 18228698
• Report Number: 1823260-2023-03786
• Device Sequence Number: 20252403
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 02/08/2024

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: 11/06/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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