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

Catalog Number 04625374160

Device Problem Defective Component (2292)

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

Event Date 10/17/2018

Event Type  No Answer Provided  

Event Description

Got a notice that the test strips that i was using in the machine were affected test strips.

• Brand Name: COAGUCHEK
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; 9115 hague rd; indianapolis IN 46250
• MDR Report Key: 8133380
• MDR Text Key: 129481922
• Report Number: MW5081831
• 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: 12/01/2018

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
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 31404821
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 102