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

Catalog Number 04837738001

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s device was requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Occupation is lay user/patient.

Event Description

The initial reporter stated they had an issue with the display for the coaguchek xs meter, which could affect the interpretation of the customer¿s results.The device¿s display has faded segments, making the display difficult to read.No actual misinterpretation of a result occurred.

Manufacturer Narrative

The customer's meter was returned.The device did not turn on during investigation, therefore the error log could not be read out.Meter was disassembled for further investigation.The visual inspection of the printed circuit board revealed contamination due to residues of fluid ingress (e.G.Leaked battery acid, cleaning solution).The contamination on the battery contacts caused a power interrupt, therefore it is not possible to turn on the meter.Furthermore, the contamination can lead to the mentioned problem with missing or weak represented segments in the display.The residues are visible in the area on the printed circuit where communication with the display takes place.This malfunction is related to a user error.The root cause is contamination of the contacts due to improper handling or maintenance.

• 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: 9916518
• MDR Text Key: 220890549
• Report Number: 1823260-2020-00911
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1