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

Catalog Number	04837738001
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of "vastly different" results on a coaguchek xs meter.It was determined the patient had changed the batteries in the meter on (b)(6) 2023 and the units were not reset to inr; the results were in seconds (sec) unit of measure.The call agent assisted with resetting the meter to read in inr unit of measure.Discrepant results in inr from (b)(6) 2023 were identified.The result at 12:52 p.M.Using strip lot 68883822 (expiration 30-sep-2024) was 4.7 inr.The result at 3:54 p.M.With a different finger using strip lot 66283721 (expiration 30-jun-2024) was 2.8 inr.The patient¿s therapeutic range is 2 -3 inr with a testing frequency of every 2 weeks.
Additional Manufacturer Narrative
Section e3: occupation is patient/consumer the coaguchek xs test strip lot number was 68883822 with an expiration date of 30-sep-2024.The coaguchek xs test strip lot number was 66283721 with an expiration date of 30-jun-2024.All strip lots include the updated labeling and states: "caution: the coaguchek xs meter is pre-set to display results in the international normalized ratio (inr).The meter is also capable of displaying results in seconds (displayed on meter as sec) and % quick (displayed on meter as %q) (a measuring unit used mainly by healthcare professionals in europe).When testing for inr, you must confirm that the measured result is displayed in inr prior to using the result and whenever the date and time settings are modified.To reset the measuring unit to inr, follow the instructions in the testing a blood sample section of the coaguchek xs system user manual for self-testing, version 8.0 and higher or call the roche diagnostics technical service center at 1-800-428-4674 for assistance, if the result is displayed in %q or sec." 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 meter and test strips were requested for investigation.
Additional Manufacturer Narrative
The meter and test strip lot 68883822 were received for investigation where they were tested using retention controls.Level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.3 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 and qc lot.All measurements were without error messages.The investigation did not identify a product problem.The cause of the event could not be determined.Sections 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: 18148454
• Report Number: 1823260-2023-03623
• Device Sequence Number: 6875305
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 12/04/2023

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: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DILT-XR; LISINOPRIL; METOPROLOL; UNSPECIFIED THYROID MEDICINE; WARFARIN
• Patient Age: 83 YR
• Patient Sex: Female