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

Catalog Number	04837738001
Medical Device Problem Codes	Circuit Failure (1089); Failure to Power Up (1476); Battery Problem (2885); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coaguchek xs serial number is (b)(6).The meter was requested for investigation.The investigation is ongoing.Section e3: occupation is patient/consumer.
Event or Problem Description
There was an allegation of burning on coaguchek xs meter, serial number (b)(6).Customer stated the meter would not power on and one of the batteries had corroded and leaked in the battery compartment.They attempted to change the batteries and noticed there was a black/burnt spot on the battery door as well as a melted spot on the bottom of the battery door.There was no harm to the patient.
Additional Manufacturer Narrative
The customer did not return the meter for investigation.Without these materials to investigate, a specific root cause for the black/burnt and melted spot could not be determined.
Additional Manufacturer Narrative
The customer coaguchek xs meter serial number up02143305 was returned.The meter was visually inspected and it was found the battery contacts are contaminated due to leaked oem batteries.During the investigation, it was confirmed that a blackened and burnt spot, along with a melted area, was found on the battery door.This damage was caused by leaked and corroded oem batteries.The customer allegation was confirmed.

• 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: 21375125
• Report Number: 1823260-2025-00430
• Device Sequence Number: 15568194
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 03/25/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 03/07/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/24/2025; 03/25/2025
• 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