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

Catalog Number 04625315003

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Thromboembolism (2654); Ischemia Stroke (4418); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

Occupation is lay user/patient the test strips were requested for investigation.Routine retention testing is performed.Test strip retention samples passed the internal inspection.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." this event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

We have received an allegation of a stroke while using the coaguchek xs meter serial number (b)(4).On (b)(6) 2021, the patient suffered a thromboembolic stroke and needed hospitalization for one day.Upon being admitted to the hospital, the result from the laboratory was 1.77 inr.The laboratory method was unknown.The patient stated he had various diagnostic examinations carried out during hospitalization confirmed that several small thrombi were found on the artificial heart valve.The hospital suspects that one of them must have come loose and caused the stroke.The patient could not say exactly which examinations were carried out.The patient was released from the hospital on (b)(6) 2021.The last result from the meter before the event was 2.9 inr on (b)(6) 2021.The patient was told he needed to go back to the hospital on (b)(6) 2021 for a "swallowing echo" procedure.The patient's therapeutic range was 2.0-3.0 inr at the time of the stroke.The patient's therapeutic range was increased to 3.0-3.5 inr after the stroke.

Manufacturer Narrative

The returned test strips were measured using the returned meter with two high level control samples: testing results (qc range: 2.5 - 3.1 inr): qc 1: 2.7 inr.Qc 2: 2.7 inr.Qc 3: 2.8 inr.Testing results (qc range: 4.1 ¿ 6.8 inr): qc 1: 4.7 inr.Qc 2: 4.8 inr.Qc 3: 4.8 inr.All inr values were within the specified target ranges, confirming the functionality of the complained coaguchek measuring system.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch field a2 has been updated.

Manufacturer Narrative

Last five inr results from the meter before the event: (b)(6) 2021 2.8 inr; (b)(6) 2021 2.9 inr; (b)(6) 2021 2.3 inr; (b)(6) 2021 2.3 inr; (b)(6) 2021 2.1 inr; (b)(6) 2021 2.4 inr.The medical assessment concluded, that further inr results as observed in the meter's memory file show a well stabilized anticoagulation effect within the therapeutic range in the course of more months.The underlying disease (artificial heart valve) is prone to clot formation.Thromboembolic events cannot be totally excluded even within the therapeutic range also for well stabilized anticoagulated patients.The elevation of therapeutic range post-event (from 2.0 - 3.0 inr to 3.0 - 3.5 inr) is indicating that the therapeutic range before the event has been rated as insufficient and allows to conclude that the thromboembolic event, in this case, was not believed to have been caused due to the meter performance.There is no indication that reasonably suggests the contribution of the device performance to the thromboembolic event.The patient code has been 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
• MDR Report Key: 12013220
• MDR Text Key: 267503613
• Report Number: 1823260-2021-01755
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

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: Health Professional
• Device Catalogue Number: 04625315003
• Device Lot Number: 44950611
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 05/18/2021
• Supplement Dates FDA Received: 06/18/2021; 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; CANDESARTAN; MARCUMAR; SIMVASTATIN
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 100