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

Model Number XS PST

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

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 a coaguchek xs meter.The reporter stated when a test strip was inserted into the meter the code number of "419" displayed as "417." the code number is made up from the results field segments.The issue with the code number could impact the interpretation of results.The code key was removed and checked; the code number on the code key was "419." a display check was performed and all segments in the results field were complete.The reporter inserted another test strip into the meter and the code number displayed as "419" correctly.

Manufacturer Narrative

The customer's meter was received for investigation.The display showed no issues during the investigation the device has been disassembled and its electronic compartment has been visually inspected.No contamination or other abnormalities are visible.No root cause or any other evidence for missing segments were found.The mentioned problem could not be reproduced.Medwatch fields d10 and h3 were 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: 10372809
• MDR Text Key: 202051703
• Report Number: 1823260-2020-01903
• Device Sequence Number: 1
• Product Code: GJS
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1