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

Catalog Number 07210841190

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The product was requested for investigation.

Event Description

The initial reporter complained of a time and date issue on 2 coaguchek pro ii devices with serial numbers (b)(4) (meter a) and (b)(4) (meter b).The customer states the time and date documented with patient results is not the time and date the actual results were obtained.This issue could affect the interpretation of patient results.Meter a has firmware (b)(4) and was docked at 12:49 p.M.On (b)(6) 2019.The patient results from that day are correct and were transmitted to the cobas it 1000 software with the date of (b)(6) 2019.Three patients were tested on meter a on (b)(6) 2019.The meter was docked with a time of 12:57 p.M.On (b)(6) 2019 but the times and date transmitted to the cobas it 1000 software for the patients tested were (b)(6) 2019 with times of 2:42 a.M., 2:43 a.M.And 2:53 a.M.The qr code on meter a also had the incorrect date.On (b)(6) 2019 8 patients were tested on meter a and the date transferred to the cobas it 1000 software was the correct date of (b)(6) 2019.Meter b has firmware (b)(4).On (b)(6) 2019 meter b was docked at 1:40 p.M.On (b)(6) 2019.The patient results from that day are correct and were transmitted to the cobas it 1000 software with the date of (b)(6) 2019.Nine patients were tested on meter b on (b)(6) 2019.The meter was docked with a time of 9:11 a.M.On (b)(6) 2019 but the times and date transmitted to the cobas it 1000 software for the patients tested were (b)(6) 2019 with times between 10:09 a.M.And 10:36 a.M.The qr code on meter b also had the incorrect date.On (b)(6) 2019, after docking meter b at 9:11 a.M., 3 patients were tested with a date of (b)(6) 2019 and the date transferred to the cobas it 1000 software was the correct date of (b)(6) 2019.

Manufacturer Narrative

On the morning of (b)(6)2019, the operator of meter serial number (b)(4) stated the battery of the meter was empty and charged the meter via a cable rather than docking it on a docking station.After a few hours charging the meter, the operator measured patients and docked the meter afterwards.The customer did not return meter serial number (b)(4).Meter serial number (b)(4) was received for investigation and upon receipt, the battery was completely empty.After charging the meter for several hours, the meter was tested in order to try to reproduce the customer's issue.A patient test with retention control solution was performed to check if the obtained result is linked to the correct date and qr code.The meter worked as specified as the date and qr code were correct.After more than 24 hours of the meter being docked, a second patient test was performed using retention control solution.The date, time, and qr code were correct.No errors were found.A handling error was identified as the battery was empty and the date/time was not adjusted after the meter was charged with the power cable.Product labeling instructs the customer to check the meter for correct date and time before every measurement.Medwatch fields concomitant medical products and device evaluated by mfr have been updated.

• 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: 8951334
• MDR Text Key: 204448414
• Report Number: 1823260-2019-03186
• 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: 09/23/2019

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 Catalogue Number: 07210841190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1