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

Catalog Number 03666794001

Device Problems Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535); Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

The meter and strips were requested for investigation, however, only the meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr.Qc 2: 5.5 inr.Qc 3: 5.3 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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 results alleged by the reporter were not observed in the meter¿s patient result memory.The reporter alleged receiving error 3.Review of the meter error log revealed that a series of error 3 (349) occurred in 2023.The meter error log revealed that customer had been attempting to test with test strip lot #54146310 code key #s_477 that had expired on 31-dec-2022.Therefore, the meter responded appropriately by triggering the error 3 message.The reporter alleged receiving error 6.Review of the meter error log revealed error 6 (662).Error 6 (662) occurs due to errors in operation by the operator, e.G.When the test strip was moved or re-moved during the measurement, or if a wet test strip was used, or the strip was already used before and reinserted.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.Na.

Event Description

We received an allegation of questionable inr results for 1 patient tested with coaguchek xs meter serial number up01504764.The meter was set to the incorrect unit of sec and the date was also incorrect.It was also alleged that errors 3 and 6 occurred on the meter.On (b)(6) 2023 the nurse reportedly alleged that on 30-jan-2023 the patient had a meter result of 1.9 inr and this result was not observed in the meter memory.And then the patient had meter results of 1.0 inr and 1.1 inr.The time difference between the measurements of 1.0 inr, 1.1 inr and the 1.9 inr is unknown.The patient's therapeutic range was 2.5-3.5 inr and the interval of testing is weekly.The lot number and the exipration date of the test strips used were not provided.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16515983
• MDR Text Key: 311255020
• Report Number: 1823260-2023-00747
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/09/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PLAVIX.; WARFARIN.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG