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

Catalog Number 03666794001

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

A display check was performed there were missing segments in the middle of the screen and at the top of the screen.There was a little corrosion found in the battery compartment around the coils.The meter was requested to be returned for investigation.The investigation is ongoing.

Event Description

There was an allegation of a display issue with the coaguchek xs meter.The reporter stated when the meter is powered on, she only sees segments at the top left and top right of the screen.When test strips are inserted, she can see segments in the middle of the screen and at the top left and top right of the screen.However, some of the segments were flashing.The reporter alleged she could not read any numbers as she only sees segments that weare part of the numbers.There was no allegation of an actual result misinterpretation.

Manufacturer Narrative

The suspect meter was received and disassembled for further investigation.It was found the circuit board was contaminated and corroded by penetrated liquid.This contamination also affected the conductive rubber contacts the root cause of the display issue was contamination of the contacts due to improper user handling or maintenance.There was no malfunction of the device.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18371908
• MDR Text Key: 331175566
• Report Number: 1823260-2023-04155
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

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
• Device Lot Number: 66283812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1