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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strips' lot number and expiration date were not provided.The patient was advised to stop attempting to use the meter and consult a doctor for an alternate test method until a replacement meter arrives.The coding procedure was reviewed with the patient and the patient was assisted with locating the matching code key that corresponds to the new vial.The investigation is ongoing.
Event or Problem Description
We received an allegation about a coaguchek xs meter displaying the incorrect chip code number.The patient alleged that the meter flickered different code numbers (116 and then 115) back and forth during the same strip insertion.The patient determined that the chip code key inserted in the meter was 106.On the call, a display test was performed and the display appeared to be complete.
Additional Manufacturer Narrative
The meter was received for investigation.The meter was powered on and a display check was performed; no missing segments were observed.The meter was tested to confirm the full functionality of the display; no issues were observed with the code number displayed after test strip insertion.The returned meter was tested within retention test strips and controls; no functionality issues were observed and no segments were missing.The investigation did not identify a product problem.Medwatch fields d9 and h3 were updated.

• 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: 17868356
• Report Number: 1823260-2023-03178
• Device Sequence Number: 5494000
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/03/2023

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
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/03/2023
• 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: Female