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

Catalog Number 04837738001

Device Problems Display Difficult to Read (1181); Image Display Error/Artifact (1304)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.

Event Description

We received an allegation of a display issue with a coaguchek meter.The reporter stated that the meter was broken.Upon changing the batteries, the meter powered on but the screen did not fully show the display.The reporter stated that the meter had missing segments on the display which impacts patient result interpretation.A display check was performed.The reporter stated that "000" was visible but the eights were not seen; the segments were missing.Upon pressing "m" for the meter memory, there was only "32.00" on the upper right of the screen.

Manufacturer Narrative

Medwatch fields d9 and h3 were updated, the meter was received for investigation.The investigation determined that the device could not be turned on.The device data and fault memory could not be read out.The circuit board was tested for damage or contamination.The battery contacts and printed circuit board (pcb) were contaminated by penetrated liquid (leaked battery) which corroded the solder contacts.This affected the battery contacts and the conductive rubber contacts on the circuit board and caused an interruption.The investigation determined that the event was caused by the contamination of the contacts due to improper handling or maintenance.Product labeling states: "if you store the meter for a period of time, remove the batteries." "please follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Do not use sprays of any sort.Ensure that swab or cloth is only damp, not wet." "wipe away residual moisture and fluids after cleaning the housing.".

• 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: 17560404
• MDR Text Key: 321692236
• Report Number: 1823260-2023-02662
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 10/12/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/12/2023
• 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