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

Model Number XS PST

Device Problem Circuit Failure (1089)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient the meter was requested for investigation.This investigation is ongoing.Unique identifier (udi) #: (b)(4).

Event Description

We received a report of an issue with the meter display on coaguchek xs meter serial number (b)(4).The customer stated they were unable to use the meter as the strip code was not appearing on the meter display.The customer performed a display check and saw 888 all segments present.The customer inserted a strip, the meter beeped but no code was on the screen.The customer turned the meter off and inserted a new strip and an error occurred.The customer was advised to clean the heater plate and let it dry.The customer powered the meter on and inserted a strip, the meter beeped as though it had detected the strip but the issue persists and no code appeared on the screen.

Manufacturer Narrative

The customer's meter was received for investigation.The customer's display allegation could not be reproduced.The test strip port was observed to have contamination on the test strip pins.The root cause of the alleged error is determined to be contamination of the contacts due to improper handling or maintenance by the customer.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: 11589199
• MDR Text Key: 268504248
• Report Number: 1823260-2021-00955
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1