MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK PRO II; PROTHROMBIN TIME MONITOR

Catalog Number 07210841190

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of a coaguchek pro ii meter indicated that the current date was (b)(6) 2018 which could impact the interpretation of patient results.The customer stated that less than one half of an hour later the meter synchronized by docking with the it1000 and the time was correct.The previous measurements were still stored in the meter.There was no allegation of an adverse event.

Manufacturer Narrative

The customer confirmed that the error was an operator mishandling issue.

• Brand Name: COAGUCHEK PRO II
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8342626
• MDR Text Key: 136244531
• Report Number: 1823260-2019-00612
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07210841190
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1