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

Catalog Number 03666794001

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The patient's meter was requested for return.The product has not been received at this time and is not expected to be returned.If the product is returned in the future, a follow-up report will be submitted.The investigation is ongoing.

Event Description

There was an allegation of a display issue with the coaguchek xs meter.The patient stated there was a "set + date flash." the patient replaced the meter's batteries and set the meter.The patient noticed the bottom segment was missing in the "o" when setting the beeper to on.The patient performed a check result in the meter's memory and confirmed no segments appeared to be missing.

Manufacturer Narrative

The customer's meter was returned for investigation.The display showed no error during investigation and the circuit board had no signs of contamination or defect.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12165139
• MDR Text Key: 261468835
• Report Number: 1823260-2021-02014
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1