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

Catalog Number 04625374160

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 02/19/2023

Event Type  malfunction  

Manufacturer Narrative

The reporter's meter and one (1) test strip were provided for investigation where they were tested using retention controls.A replacement meter was sent.Testing results (qc range = 4.1¿ 6.8 inr): qc 1: 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 results listed in units of %q alleged by the customer were observed in the meter¿s patient result memory.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. per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods."  the patient's results were in % quick.Product labeling 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." the same finger was used when repeat testing was performed.Product labeling states "if you need to redo a test, use a new lancet, a new test strip, and a different finger." the investigation did not identify a product problem.The cause of the event could not be determined.  section e3 - occupation: patient/consumer.The reporter is the patient's wife.

Event Description

We received an allegation of questionable % quick results for one patient tested with the coaguchekxs meter with serial number up01636295.The reporter stated that the meter did not power on, so she changed the batteries.The meter is powered on and was in setup mode.She then reset the time and date and when she tested the patient, the meter results were in %q (% quick).The meter result at 11:00 am was 19 % q.The first repeat meter result at 11:00 am was 21 % q (the same finger was used). the second repeat meter result at 11:00 am was 27 % q.  the reporter was assisted in setting the date, time, and units to inr.The meter result at 11:00 am was 2.7 inr.The first repeat meter result at 11:00 am was 2.5 inr. the second repeat meter result at 11:00 am was 2.1 inr.  the patient's therapeutic range is 2.0 to 3.0 inr.  the interval of testing is once a week.

Manufacturer Narrative

Medwatch field b3 - date of event was updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• 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: 16577515
• MDR Text Key: 311683319
• Report Number: 1823260-2023-00888
• 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,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 62682421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2023
• 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: ALDACTONE; AREDS 2; CALCITRIOL; CARVEDILOL; COMBIGAN; ENTRESTO; FINASTERIDE; JARDIANCE; KLOR-CON; LASIX; MIRALAX; TAMSULOSIN; TRAVATAN; VITAMIN B12; VITAMIN D3; WARFARIN
• Patient Age: 94 YR
• Patient Sex: Male
• Patient Weight: 68 KG