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

Catalog Number	04837738001
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e3: occupation is patient/consumer the meter was requested for investigation.
Event or Problem Description
We received an allegation of an issue with a coaguchek xs meter.The patient alleged running a test on the meter and receiving an error 5 message and then a result of 1.6 inr with the same test strip.An error 5 is related to an issue applying blood to the test strip.The patient reported the result of 1.6 inr.
Additional Manufacturer Narrative
The meter was received for investigation.Sections d9 and h3 were updated.The returned meter was tested using retention strips and retention controls.Level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.2 inr.Level 2 testing results (qc range = 2.4 - 3.6 inr): qc 2: 2.8 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The alleged result of 1.6 inr on (b)(6) 2023 was not observed in the meter's patient result memory.The patient alleged receiving an error 5 on (b)(6) 2023 before the result of 1.6 inr.A review of the error log showed that error 5 occurred on (b)(6) 2023.Error 5 occurs when the applied sample volume is insufficient or when sample detection is uncertain.Generally, this is caused by wrong handling, or by meter contamination.A review of the meter error log showed that the only error to have occurred on (b)(6) 2023 was error 6 which occurs as a result of the on/off-button having been pressed during a measurement.Examination of the heater plate of the meter also revealed heavy contamination due to customer mishandling.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The returned material and the retention material meet the specifications.The investigation did not identify a product problem.

• 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: 18464259
• Report Number: 1823260-2024-00068
• Device Sequence Number: 7079224
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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): 01/16/2024

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: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WARFARIN
• Patient Sex: Male