MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS, INC. COAGUCHEK XS PT TEST 2X24 STRIPS; TEST, TIME, PROTHROMBIN

Model Number 04625315160

Device Problems Nonstandard Device (1420); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Event Description

Device used for coumadin blood level.Inr test strips showed extra high blood level of 3.8.(b)(6) recalls and lot no: 29415113 were listed that were used for this inr.Fda safety report id# (b)(4).

• Brand Name: COAGUCHEK XS PT TEST 2X24 STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8670522
• MDR Text Key: 147098143
• Report Number: MW5087102
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/31/2019

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: 05/31/2019
• Device Model Number: 04625315160
• Device Lot Number: 29415113
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PENICILLIN VK 500 MG; WARFARIN HYDROCHLORATHIAZIDE
• Patient Age: 83 YR