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

Catalog Number 04625374160

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

Patient Problems Patient Problem/Medical Problem (2688); Insufficient Information (4580)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient alleges in a legal document that the patient "has been seriously and severely injured, was rendered sick, sore, lame and disabled, exacerbation of prior conditions, and suffered from, among other things, stroke, intellectual impairment, physical impairment, and permanent disabilities." medical assessment of the event concluded, information necessary to determine whether the coaguchek contributed to the stroke event was not provided.If further information is received a supplemental report will be filed.In general, strokes may be related to insufficient anticoagulation and other, anticoagulation independent conditions.The patient group with the need for anticoagulation is not treated curatively by anticoagulation.Anticoagulation only reduces the consequences and complications of the underlying disease, but risks remain.In case of insufficient anticoagulation, several reasons might have led to this (e.G.Not optimal therapeutic range due to co-morbidities, irregularities of medication intake/dosages, irregularities of life-style, co-medication, co-morbidities, etc.).No product is expected for return.Routine retention testing is performed.Test strip retention samples passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.The investigation did not identify a product problem.The cause of the event could not be determined.Reporter occupation is lay user/patient.Unique identifier (udi): (b)(4).

Event Description

An allegation was received via a legal letter related to a patient having a stroke due to "incorrect and inaccurate" inr results from a coaguchek xs system with an unspecified serial number.The patient had a stroke in (b)(6) 2018.The date of event is an approximation as the actual date of the stroke was not provided.No specific patient information has been provided.The patients therapeutic range, medications and medical history were not provided.No specific details related to the event have been provided.No inr results have been provided.No information related to changes in vitamin k antagonist (vka) therapy has been provided.No diagnostic results related to the event have been provided.It is not known what type of stroke the patient had (ischemic/hemorrhagic) or the location of stroke.No information related to how the patient was treated has been provided.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Patient code 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
• MDR Report Key: 11401840
• MDR Text Key: 234454206
• Report Number: 1823260-2021-00644
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other