MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PT TEST - 6 TEST, ROCHE INR TEST STRIPS; TEST, TIME, PROTHROMBIN

Model Number 04625374

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

The inr test strips readings could have caused major deadly results.We experienced many adverse reaction to self due to faulty reading.Weekly inr tested with coagulation meter and coaguchek xs pt test strips to determine amount / dosage of warfarin to be dispensed by dr (b)(6).Now they sent new test strips, but found out same ones on recall - the other not on production yet.They are to send new meter and strips and return the other one we use.Inr extreme high reading and/or irregular reading which lead to warfarin adjustments.Defective strips for inr readings; coaguchek xs pt test 6 test, test strips.

• Brand Name: COAGUCHEK XS PT TEST - 6 TEST, ROCHE INR TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8089567
• MDR Text Key: 128246660
• Report Number: MW5081462
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 04625374
• Device Lot Number: 28632021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86