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

Catalog Number 03666794001

Device Problems Image Display Error/Artifact (1304); Failure to Power Up (1476)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is patient/consumer.The meter was requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.

Event Description

We received an allegation of a display issue on coaguchek xs meter serial number (b)(4).On (b)(6) 2023 it was reported that the meter's display was unclear.Even after replacing batteries, the meter was no longer powering on.The last successful test was in (b)(6) 2022 and the date of event was approximately (b)(6) 2022.The patient had a meter result of 1.6 inr.The display was unclear.The patient's anticoagulation dose was increased based on the meter result.There was no harm or adverse events after increasing dose.The patient had been advised not to use a meter with an unclear display.The patient's therapeutic range was not provided.

Manufacturer Narrative

The meter was not returned for investigation.As no product was returned, a specific root cause 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16387341
• MDR Text Key: 310209089
• Report Number: 1823260-2023-00476
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 04/03/2023
• 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
• Treatment: ANTICOAGULATION MEDICATION.