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

Catalog Number	03666794001
Medical Device Problem Codes	Display Difficult to Read (1181); No Display/Image (1183); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On the call, a display check couldn't be done on the meter due to loss of power.The meter was provided for investigation.The investigation is ongoing.
Event or Problem Description
We received an allegation about a display issue on a coaguchek xs meter.The patient alleged that the meter turned on with a faded display too faint to read then it turned off.He replaced the batteries with new ones.The patient wasn't able to run a test as the meter did not power back on.
Additional Manufacturer Narrative
The device code (a code) was updated.The patient's device was provided for investigation.The device could not be turned on.The device data and the fault memory could not be read out.The circuit board was tested for damage or contamination.The battery contacts and the printed circuit board were contaminated by the liquid from the leaked battery which had penetrated and corroded the solder contacts.The root cause was contamination of the contacts due to improper handling or maintenance.The investigation did not identify a product problem.

• 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: 17976556
• Report Number: 1823260-2023-03372
• Device Sequence Number: 2454208
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• 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): 11/13/2023

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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/13/2023
• 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