MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Model Number XS PLUS

Device Problem Failure to Transmit Record (1521)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

There was an allegation of an issue with the software for a coaguchek xs plus meter.A meter result of 2.4 inr was taken on (b)(6) 2022 at 00:03.The customer could not find the result in their (rals) system.Upon review of the meter memory, the result was in the meter memory as being taken on (b)(6) 2021.The result was transferred to the correct patient but had the wrong date.The test strip lot number and expiration date were requested, but not provided.The patient's therapeutic range was requested, but not provided.

Manufacturer Narrative

A result taken, for a different patient prior to the one alleged, showed the correct date on the meter.The customer claims the current date and time on the meter are correct.No results were taken with the meter after the alleged issue occurred.The meter was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

Fields d9 and h3 were updated to reflect returned product.The alleged meter was returned for investigation.During the investigation, the meter's error log was reviewed.The alleged patient result, which did not appear in the customer's (rals) system at the customer site, was found available in the patient result list (not sorted according to date).The report showed an error (e-101) on line 18 dated back to (b)(6)-2021.The errors before and after line 18 are dated (b)(6) 2022.The patient result log, that was read out by the customer using their (rals) system was not forwarded to the investigation unit for investigation.Therefore, data sorting by date in the customer's system (rals) couldn't be confirmed.Measurements were performed using the returned product to reproduce the alleged issue.Once the patient result log was emptied, the error code collection (ecc) tool could read out the new measurements.The device was connected to the roche data management system in order to check if the measurement results were transferred to the roche data management system.The measurements appeared in the roche data management system successfully.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 14170395
• MDR Text Key: 298993280
• Report Number: 1823260-2022-01135
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945726
• UDI-Public: 4015630945726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XS PLUS
• Device Catalogue Number: 04562780001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/19/2022
• 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
• Patient Sequence Number: 1