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

Device Problems Failure to Calibrate (2440); Calibration Problem (2890)

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

Event Type  malfunction  

Event Description

Test strip calibrated wrong.Brand was roche.

• Brand Name: COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8106194
• MDR Text Key: 128578851
• Report Number: MW5081617
• 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: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 100