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

Catalog Number 04625374160

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2018

Event Type  Death  

Manufacturer Narrative

This allegation was received via legal letter.Attorney.Unique identifier (udi) #: (b)(4).Reason device not evaluated by mfg: the product has not been returned to the manufacturer.

Event Description

It was alleged the patient presented to the hospital with stroke symptoms on (b)(6) 2018.The patient was using a coaguchek xs meter with an unknown serial number.On the day of the event, the result from the meter was reported to have been therapeutic between 2.5 and 3.5 inr.The actual result from the meter was not provided.Upon arrival at the hospital, his inr was 1.8 and sub-therapeutic.It was alleged the patient did not recover from the stroke and spent months convalescing before he passed away from associated complications.The patient passed away on (b)(6) 2019.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The patient reportedly used a roche meter and the coaguchek test strips to monitor his inr while taking coumadin at the time of the event.The strip lot the patient was using around the time of the event was not provided.The patient's meter and strips were not returned for investigation.It may be possible that the test strips used at the time of this event were from one of the lots affected by the 2018 coaguchek test strip recall (lots #272 167 up to #334 498).These strips were calibrated according to who material rtf/16.Investigations of these test strip lots found an unexpected increasing positive bias if the inr was > 4.5 and that results are reliable from 0.8 to 4.5 inr, since the calibration data covers this measuring range very well.Due to these findings, customers were notified in september 2018, that roche decided to limit the use of the available coaguchek strips (xs pt, xs pt pst, and pt - calibrated to rtf/16) to the range of up to 4.5 inr, which is in accordance to the validation of the who standard.In this notification, customers were informed that any inr test result received above an inr of 4.5 on a coaguchek meter needed to be confirmed with another testing method (e.G., lab test) and recommended increasing the frequency of monitoring for these patients until their results fall below 4.5 inr.At the beginning of (b)(6) 2018, a recall notification was sent to all customers to inform them to discontinue the use of and discard all affected strips (lots #272 167 up to #334 498).At the beginning of 2021, all of the affected test strips expired.Before the recalled strip lots, coaguchek test strip lots in the market were calibrated to the former who material rtf/09.It cannot be excluded that the patient used an unaffected test strip lot at the time of the event.The retention material of the rtf/09 test strips complied with the specification over the whole time frame of their durability for the whole measuring range of the system.

Manufacturer Narrative

In (b)(6) 2019 during a hospital stay for a valve replacement, the patient¿s digoxin was discontinued and the patient was put on amiodarone 200 mg daily for recurrent atrial flutter/fibrillation with rapid ventricle response.After initiating therapy with amiodarone, the patient developed rapidly within 2 months signs of respiratory failure with persistent hypoxemia and low pco2.In (b)(6) 2019, acute hypoxic respiratory failure occurred and a ct scan confirmed the progressive interstitial lung disease, most possibly induced by amiodarone and the patient was discharged with a "poor prognosis" to home with hospice services.The death of the patient was caused by interstitial lung disease most probably related to amiodarone toxicity.The coaguchek xs meter did not contribute nor cause the death of the patient.Also, the event in (b)(6) 2018 did not contribute to nor cause the death.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12182015
• MDR Text Key: 262061465
• Report Number: 1823260-2021-02065
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

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: Lay User/Patient
• Device Catalogue Number: 04625374160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 06/18/2021; 11/12/2021
• Supplement Dates FDA Received: 09/10/2021; 12/09/2021
• 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: ATORVASTATIN; CLOPIDOGREL; COUMADIN; FISH OIL; FOLIC ACID; HYDROCHLOROTHIAZIDE; ISOSORBIDE MONONITRATE; LISINOPRIL; METFORMIN; METOPROLOL TARTRATE; NITROSTAT; COUMADIN
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Male