MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PRO KIT INTERNATIONAL; COAGUCHEK ® XS SYSTEM

Catalog Number 05530199190

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

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

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of a time and date issue with 17 coaguchek xs pro meters with software version 03.01.04.Refer to attached data for the serial numbers of the affected meters.On (b)(6) 2017 meters with patient test results were docked in the base unit.The results were successfully sent to the customer¿s data management system and the dosing physicians.Afterwards, some of the meters were connected to a power cable over the weekend.On (b)(6) 2017 nurses took the meters and began to test patients.These results were sent with the incorrect time and date of (b)(6) 2017 to the customer¿s data management system and the dosing physicians.At this time, it was noticed that the meters had the wrong time and date listed with the results.The time and date was manually changed to the correct time and date.After rebooting the device, the time and date was correct for new test results but not on the test results stored in the meter memory.There was no allegation that an adverse event occurred.The issue could be reproduced at the investigation site with a retention meter that was charged on a base unit.The date stayed "frozen" at (b)(6) 2017.The investigation was also able to run a test with the incorrect date and the result was stored with the incorrect date.The investigation also powered the device off and back on.Afterwards, the date was correct for new tests, however, the results in the memory were still stored with the incorrect date.Investigations are ongoing.

Manufacturer Narrative

The customer returned meter with serial number (b)(4).The software issue was confirmed during the investigation with a retention meter and the customer's meter.The clock stops every 2^32 milliseconds at the specific date and time when the device is docked in a base unit.This issue does not affect the actual results produced by the device.New meter firmware will be developed to fix the issue.As a work around, it is recommended to turn the meter off and back on.When this is done, the time of the meter is updated automatically.

• Brand Name: COAGUCHEK XS PRO KIT INTERNATIONAL
• Type of Device: COAGUCHEK ® XS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7071420
• MDR Text Key: 94222630
• Report Number: 1823260-2017-02793
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

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: Nurse
• Device Catalogue Number: 05530199190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1