MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS, INC. TEST STRIPS FOR COAGUCHEK XS PT TESTER; TEST TIME PROTHROMBIN

Model Number 04625374160

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

Patient Problem Test Result (2695)

Event Date 09/20/2018

Event Type  Injury  

Event Description

Coaguchek, i do at home inr checks every two weeks - my last two tests were much higher than my normal inr value, but still within range.The last time ((b)(6) 2018) i went online to report the test value, i was alerted to a message that stated: urgent medical device correction.I printed out the information and was appalled that i could keep using the test strips that were identified as defective as long as my inr was not above 4.5.That value is way above the acceptable high value of 3.0.A user could possible bleed to death if the inr were truly at that level.Surely you are aware of the problem, but why isn't there a written or email alert to all users? and why are we told that we can continue to use the defective test strips?.

• Brand Name: TEST STRIPS FOR COAGUCHEK XS PT TESTER
• Type of Device: TEST TIME PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 7910497
• MDR Text Key: 121988346
• Report Number: MW5080131
• 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: 09/21/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: 04625374160
• Device Lot Number: 30497423
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 73