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

Catalog Number 03666794001

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.

Event Description

The initial reporter complained of a display issue with coaguchek xs meter serial number (b)(4).After replacing the batteries, the customer noticed segments missing in the results field of the device.Upon performing a display check, all results segments were visible.The customer stated there was a crack on the upper casing of the meter due to dropping it.The crack was not on the display screen.

Manufacturer Narrative

The customer's meter was received for investigation.The display showed no issues during the investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The observed contamination can temporarily lead to the reported display issue.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: 10153594
• MDR Text Key: 195119605
• Report Number: 1823260-2020-01445
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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: Health Professional
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1