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

Model Number XS PST

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The meter was requested for investigation.

Event Description

The initial reporter complained of a display issue with coaguchek xs meter serial number (b)(4).The customer stated segments were missing from the results field of the display.During a display check the meter displayed 000 instead of 888.There was no allegation that any test results had been misinterpreted.

Manufacturer Narrative

The reporter's meter was returned for investigation.Upon investigation of the returned meter, a defect in the circuit board or an electronic component of the circuit board was found.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: 12150062
• MDR Text Key: 261238397
• Report Number: 1823260-2021-01989
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 08/26/2021

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 Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1