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 10/28/2022

Event Type  malfunction  

Event Description

There was an allegation of intermittent display issues with a coaguchek xs meter.The customer stated the batteries may have been installed incorrectly.When the meter was powered on the results field displayed "88.1." instead of the correct display of "88.8." upon completion of a display check, the results field correctly displayed "88.8." the meter settings were reviewed and the meter was turned off.When the meter was powered back on the results field displayed "18.8." the meter memory was reviewed and the results field was complete.After the initial point of contact, the customer replaced the batteries and requested assistance resetting the meter.The reporter stated there were no display issues with this set of batteries.Upon completion of a display check, the results field correctly displayed "88.8." there were no missing segments.The meter memory was reviewed and there were no missing segments.The meter was powered on and "88.8" appeared correctly.The meter was powered on by inserting a test strip and the code number displayed correctly with no missing segments.

Manufacturer Narrative

Reporter occupation is patient/consumer.The meter was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

The meter was received for investigation.The circuit board was contaminated by penetrated liquid.This contamination affects the conductive rubber contacts on the circuit board.Upon turning on the meter, missing segments were observed.Missing segments were shown clearly when confirming the code number, the countdown for blood application, and the meter result.No plausible results were displayed.The investigation determined the root cause of the issue was contamination of the contacts due to improper handling or maintenance by the customer.

• 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: 15837661
• MDR Text Key: 307723362
• Report Number: 1823260-2022-03715
• 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: 12/12/2022

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 Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/12/2022
• 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: Female