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

Catalog Number 03666794001

Device Problem Image Display Error/Artifact (1304)

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

Event Date 11/24/2023

Event Type  malfunction  

Event Description

The customer stated they had an issue with the display of a coaguchek meter.The customer changed the meter batteries twice but was unable to select the meter settings.The display did not appear to be correct.The customer performed a display check and all segments were complete and readable.When the customer let go of the "i" button, only "am/pm", an hourglass, the word "set", and a test strip with a check mark were observed on the display.When checking results from the meter's memory, a single "8", a blood drop, the words "error", "mem", "time", and the meter icon were displayed.The customer was unable to see the most recent test result.

Manufacturer Narrative

The customer's meter was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

The meter was returned for investigation.The circuit board of the meter was tested for damage or contamination.The circuit board was found to be contaminated by a penetrating liquid.The contamination affected the conductive rubber contacts on the circuit board, which are short-circuited by this.The contamination of the device would be caused by incorrect handling.The investigation did not identify a product issue.Medwatch fields d9 and h3 have been updated.

• 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
• MDR Report Key: 18306292
• MDR Text Key: 330832261
• Report Number: 1823260-2023-03942
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/02/2024
• 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