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

Catalog Number 03666794001

Device Problems Device Difficult to Setup or Prepare (1487); Unexpected Therapeutic Results (1631); High Test Results (2457)

Patient Problems Arrhythmia (1721); Coagulation Disorder (1779)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation.The meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr; qc 2: 5.2 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 results were observed in the meter¿s patient result memory.However, the meter's time and date were set incorrectly.The customer did not realize that the coagulation result was displayed in a measuring unit different from inr.As a result, the customer incorrectly interpreted the %q result by inserting a decimal point.All strip lots include the updated labeling and state: "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." the user manual provides the steps to set the measuring unit to inr: "press the set button on the left side of the meter to enter the setup mode.First, the date format flashes in the upper-right corner.Press the set button several times to confirm date, time format, and time already set in the meter.Press the set button again to display the actual measuring unit on the display.Press the m button until the measuring unit inr is flashing.To save the measuring unit to inr, power off the meter by pressing the on/off button." the investigation did not identify a product problem.

Event Description

There was an allegation of questionable results with a coaguchek xs meter potentially contributing to a patient¿s blood clot identified during a scheduled ablation procedure.Following an investigation, it was determined that the patient¿s meter was set to %q unit of measure, and the patient incorrectly interpreted results in %q unit of measure as results in inr unit of measure.On (b)(6) 2022 the meter result was reportedly 20 %q (2.6 inr).The patient allegedly reported this result as 2.0 inr.On (b)(6) 2022 the patient was reportedly advised to stop taking warfarin because she is switching to eliquis.On (b)(6) 2022 the patient reportedly had an ablation scheduled.On (b)(6) 2022 the result from an unspecified hospital meter was reportedly 4.0 inr.The result from an unspecified laboratory method was reportedly 3.8 inr.The ablation procedure was canceled as a blood clot was allegedly identified in one of her heart appendages; it is not known which appendage.The patient was reportedly not admitted to the hospital and no treatment was received for the blood clot.The doctor allegedly said they would wait for the blood clot to dissolve on its own.The patient was reportedly not treated for inr.On (b)(6) 2022 the meter result was 37 %q (1.7 inr).On (b)(6) 2022 the meter result was 50 %q (1.4 inr).On (b)(6) 2022 the meter result was 48 %q (1.4 inr).The patient misinterpreted these results as 3.7 inr, 5.0 inr, and 4.8 inr.The patient has reportedly not started taking eliquis because her results have not been under 2.0 inr.Reportedly, no dosage changes were made based on results reported in the incorrect unit.There were reportedly no dosage changes based on the meter results leading up to the identification of the blood clot.The patient is currently at home and does not have any symptoms.The patient¿s therapeutic range is reportedly 2.0 ¿ 3.0 inr with an alleged testing frequency of weekly.The test strip lot number was 60942022 with an expiration date of 31-oct-2023.

• 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: 15996281
• MDR Text Key: 305615123
• Report Number: 1823260-2022-04043
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/16/2022
• 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: CALCIUM; LYRICA; PRESERVISION VITAMINS; VITAMIN D; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 91 KG