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

Catalog Number 03666794001

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient stated that she received an unknown error with her coaguchek xs meter serial number (b)(4).The patient tried to run a display check, but stated that she just sees "1"s on the result display.The screen was not cracked and there was no fading of the symbols that were displayed.The patient stated that she could not see "888" on the result display field.The display was only showing partial segments of the result display.The patient's product was requested for investigation and replacement product was sent to the patient.Upon first investigation of the meter, a display check was performed.Segments of the display only illuminated sporadically.

Manufacturer Narrative

The meter was returned for investigation.The meter was visually investigated and the circuit board was tested for damage or contamination.The circuit board was found to be contaminated by liquid, which had penetrated and corroded the solder contacts.The display flickered during the display test and was unstable.The cause of the issue was contamination of the meter with liquid due to improper handling or maintenance.

Manufacturer Narrative

A risk to the patient due to reading of incorrect measured values can be excluded since no meaningful number is displayed on the device.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6897142
• MDR Text Key: 89473319
• Report Number: 1823260-2017-02118
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1