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

Model Number XS PST

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.Occupation: the occupation is lay user/patient.

Event Description

The initial reporter stated there was an issue with coaguchek xs meter serial number (b)(4).The reporter stated that sometimes the code listed on the display of the meter does not match the code listed on the vial of test strips.The reporter states the numbers change on the screen and this is why the codes don't match.The reporter states that all numbers on the display screen have been changing, including the date, time, results, and test strip code.The reporter performed a display check of the meter and there were no missing segments on the display.

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 battery compartment shows contamination caused by penetrated liquid.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.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: 10189144
• MDR Text Key: 203674071
• Report Number: 1823260-2020-01524
• 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: 07/16/2020

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: 07/10/2020
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1