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

Lot Number 04625374160

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

Patient Problem Respiratory Failure (2484)

Event Date 11/06/2018

Event Type  Injury  

Event Description

Reporter alleges she got a false reading of 4.8 on (b)(6) and reported results to her cardiologist who advised her to hold coumadin for 2 days since it was above therapeutic range.On (b)(6), she was rushed to the er and ended up being hospitalized for 18 days.Reporter advised being diagnosed with respiratory failure.She received a recall notice when she got home after discharge and is convinced the false reading from the strips contributed to this adverse event.This has also been reported to the mfr.

• Brand Name: COAGUCHEK PT TEST STRIP
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS INC.
• MDR Report Key: 8194399
• MDR Text Key: 131593974
• Report Number: MW5082537
• 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: 12/21/2018

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?: No
• Device Operator: No Information
• Device Lot Number: 04625374160
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 67