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

Catalog Number 04625374160

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2020

Event Type  Death  

Manufacturer Narrative

Based on the information available, it is unlikely the coaguchek xs meter caused or contributed to the death of the patient because: the patient suffered from hemoptysis and died while he was flown to another hospital.Hemoptysis is caused by several diseases (e.G.Lung cancer, pulmonary embolism, vascular malformations, infections (e.G.Tuberculosis), heart failure or dilation of the airways), most of them are not related to a coagulation issue.Pulmonary embolism may be related to a coagulation problem.The medical history describes "heart disease" and "peripheral artery disease".The latter does not cause a pulmonary embolism.Because of the known "heart disease" (not specified), it is assumed the hemoptysis and death were caused by heart failure.This cannot be confirmed without the official cause of death which could not be provided.The inr results as provided, show results within or around the intended therapeutic range "around 3.0 inr." there is no laboratory result comparison to suggest that the results from the coaguchek xs meter were incorrect.-coaguchek retention strips of all lots currently valid in the market are tested in comparison to the current master lot.Routine retention testing was performed and passed the internal inspection.-during troubleshooting, it was verified twice that the results from the meter were displayed correctly in inr.Diagnosis at the hospital of primary care and post mortem examination is unknown.Additional information was requested but not provided.The reporter has not responded to follow-up requests.The patient's wife stated the strip box and test strips were discarded.The lot # of strips was unknown.The customers meter was requested for return.If further information becomes available or the meter is returned a follow-up report will be submitted.Unique identifier (udi) #: (b)(4).Occupation: lay user/patient.

Event Description

The patient's wife initially called on (b)(6) 2021 after receiving the umdc letter.During the call, it was verified that the patient's meter was correctly set and displayed results in inr which confirmed the meter was not impacted by the issue described in the umdc.The patient's wife called again on (b)(6) 2021 and alleged the patient's results may not have been accurate based on the umdc notification and she alleged the inaccurate results caused his death.It was again verified on the call that the patient's meter was correctly set and displayed results in inr which confirmed the meter was not impacted by the issue described in the umdc.The patient's wife provided the following details.She stated that on (b)(6) 2020, the patient started to cough up blood.The patient's wife called 911 and an ambulance took him to the hospital.From there he was put in a helicopter and transported to another hospital.The patient coded in the helicopter and died en route.The cause of death was requested but could not be provided.The last result from the meter prior to the patient's death was (b)(6) 2020 and was 2.7 inr.No inr results were provided from the date of death.It was reported the patient was not treated based on the last few results from the meter.It was also stated that the doctor decreased the coumadin by 1/2 a pill based off of either a result of 3.6 or 3.3 inr.The exact result and corresponding date of the coumadin adjustment are unknown.In reviewing the meter memory a result of 3.6 inr was measured on (b)(6) 2020 and a result of 3.3 inr was measured on (b)(6) 2020.It is unknown if these results are the results mentioned by the patient's wife.The patient's wife believes that the patient's therapeutic range was around 3.0 inr.The patient's coaguchek xs meter serial number is (b)(4).This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Section h9 was populated in error on the initial report.The umdc letter referenced in b5 is (b)(4).

Manufacturer Narrative

Request from fda: is there a death certificate and/or autopsy report for the patient? was there any inr testing in the er/hospital on the date of event (b)(6) 2020)? if so, what were the result and the lab method? response from manufacturer: we were able to contact the patient¿s wife to ask for the information you requested.She stated that the death certificate lists "sudden cardiac event" as the cause of death.Roche was not provided a copy of the death certificate.She also clarified the details of the day of the event.She stated that her husband was taken by ambulance to a nearby church where a helicopter was waiting to transport him to the hospital.It was on the helicopter flight that her husband died.The patient¿s wife also does not know if her husband¿s inr was checked while en route to the hospital.The patient¿s wife stated that she did not speak with any doctors regarding treatment of her husband in the helicopter and re-stated that she does not know if her husband¿s inr was checked while en route to the hospital.She stated that she believes he may have had a blood clot.Our medical assessment summary is that in this case, a 69 years old male patient, known to suffer from vascular calcification, died due to a sudden cardiac event.The information provided points to an acute myocardial infarction with cardiac decompensation and shock, finally leading to death.Fulminant myocardial infarction is usually not related to anticoagulation nor can it be prevented by anticoagulation as the likely root cause is the coronary vascular disease leading to increasing constrictions of coronary vessels because of progredient atherosclerotic processes.With the information provided by the user until date of today, the coaguchek system did not cause or contribute to the death of the patient.

• 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: 11476359
• MDR Text Key: 239536846
• Report Number: 1823260-2021-00774
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES86951
• Patient Sequence Number: 1
• Treatment: COUMADIN; PLAVIX; COUMADIN; PLAVIX
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 84