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

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

In anticoagulation clinic we use coaguchek xs point of care machine to monitor and adjust anticoagulation therapy with warfarin for pts with all indications for warfarin therapy.Recently we received a notice (not a recall, just a notice) from roche, the mfr of the test strips used in the machine, that when they re-calibrated the strips to meet new who standards, abnormally high inr results occurred.They are re-calibrating the new lots of test strips back to the old who standard, but have not recalled the erroneous lots.The notice advised confirming inr results >4.5 with an alternate method of testing, however in our clinic we have had pts with point-of-care results of >6 with venipuncture inr results in the 3 range (which is within therapeutic range for many of our pts).We believe the strips may not be accurate even below the roche-designated cut-off of inr of 4.5.Medication administered to or used by the pt: no.(b)(6).Access number: (b)(4).

• Brand Name: COAGUCHEK XS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8128830
• MDR Text Key: 129436235
• Report Number: MW5081790
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/22/2018

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1