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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

It was reported there was an issue with the display of coaguchek xs meter serial number (b)(4).The meter's display was faint and difficult to see.The meter batteries were replaced with two different sets of aaa alkaline batteries, but the issue persisted.A display check was performed and all display segments were visible and clear to read.However, when the power button was released, the display had some items that were flickering, very faint, and hard to see.The meter was powered off and then the meter's patient result memory was accessed.Some things were visible on the display, but the result was really faint and it was difficult to make out what was being displayed.The issue just started and there were no issues with the display last time it was used for testing.There was no visible moisture, debris, or corrosion in the battery compartment or under the test strip guide cover.The meter was not dropped or mishandled.

Manufacturer Narrative

The customer's meter was requested for investigation and a replacement was sent to the customer.Occupation - the occupation is patient/consumer.

Manufacturer Narrative

The meter was returned for investigation.The device would not turn on.The meter was disassembled and it was observed that the circuit board was contaminated due to residues of fluid ingress.The contamination can lead to the alleged display issue.Contamination on the battery contacts caused a power interruption.The contamination would be caused by a mishandling of the device.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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15293781
• MDR Text Key: 302020641
• Report Number: 1823260-2022-02553
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male