MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PLUS SYSTEM; TEST, TIME, PROTHROMBIN

Model Number XS PS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inaccurate Information (4051)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Incorrect reading from coaguchek for the past three years.After several years of readjusting the reporter¿s husband warfarin medication they received a letter in the mail from roche on (b)(6) 2020 stating that the settings on the coaguchek were incorrect.That the instructions in the manual were not accurate and they need to reset according to the new instructions enclosed."we spent years readjusting my husband¿s medication.His inr readings were consistently high and low.This could have caused something more serious to happen to my husband and has left me very upset.".

• Brand Name: COAGUCHEK XS PLUS SYSTEM
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 11125322
• MDR Text Key: 225567211
• Report Number: MW5098696
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/05/2021

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: No Information
• Device Model Number: XS PS
• Device Catalogue Number: 04837738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100