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

Catalog Number	04837738001
Medical Device Problem Codes	Image Display Error/Artifact (1304); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about a faded display when a patient tested with a coaguchek xs meter.The reporter alleged that since the meter was flickering, he replaced the batteries.He also alleged that the meter did not power on after that.The reporter was advised to turn off the meter and press the m button to access the meter memory.The meter was powered on with an error message.The reporter alleged that he could not determine if the error message was an error 4 or an error 9 as the numbers were faded.
Additional Manufacturer Narrative
The meter was requested for investigation.The reporter stated that the original batteries were not leaking.The investigation is ongoing.
Additional Manufacturer Narrative
Sections d9 and h3 were updated.The meter was provided for investigation.The error log could not be read out as the device did not turn on during the investigation.The meter was disassembled for further investigation.The optical inspection of the printed circuit board revealed contamination due to residues of fluid ingress (leaked battery acid, cleaning solution).The residues are visible in the area on the printed circuit where communication with the display takes place.The contamination on the battery contacts led to the mentioned problem with the faded segments and was the cause of the power interruption.The investigation determined there was a user error.The root cause was due to contamination of the contacts due to improper handling or maintenance.

• 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
• MDR Report Key: 18365979
• Report Number: 1823260-2023-04136
• Device Sequence Number: 18066690
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: Lay User/Patient
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/12/2024
• 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: Male