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

Catalog Number	03666794001
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2023-04155
• Device Sequence Number: 15357718
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 03666794001
• Device Lot Number: 66283812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown