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

Model Number XS PST

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Occupation was lay user/patient.

Event Description

The initial reporter experienced an issue with the coaguchek xs meter.The customer stated the meter was not powering on and while holding the meter, she stated smoke started to emit from the back end of the meter.The customer removed the battery cover and took out the batteries.The customer stated the meter was hot and the springs looked brown/burnt.The customer stated the meter was cooling down after the batteries were removed.

Manufacturer Narrative

The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The contamination (leaked battery and ingress of fluid) can lead to a short circuit in the electronics and high power consumption.A thermal reaction of the battery would be the result.No batteries were sent in for investigation.No signs of melted or burned material were observed.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.

Manufacturer Narrative

Response from manufacturer: the device was returned for investigation.Visual inspection of the housing revealed heavy contamination.The device was not able to power on.Once the meter was disassembled, it is visible that there is contamination inside the meter.The source of the contamination is not certain.Potential sources could be blood, cleaning fluid, leaky battery or other substances.There was no melted or burnt material observed.This contamination can lead to a short circuit in the electronics causing a higher power consumption which may result in a thermal reaction of the battery causing a hot meter.Smoke may have been caused by a short circuit through the liquid.The printed circuit board is protected with a fuse and is not likely to overheat or cause a fire.No batteries were returned with the meter.The investigation is still ongoing to try to determine the nature of the contamination.

Manufacturer Narrative

Response from manufacturer: the contamination was examined under a microscope.While the exact substance could not be identified, it is most likely a mixture of blood and cleaning solution.The most likely cause is improper cleaning by the customer.Please see the pictures in the attached document.Also attached are the cleaning instructions from the coagucheck xs system user manual for self testing.

• 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: 10420375
• MDR Text Key: 203347694
• Report Number: 1823260-2020-02027
• 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,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1