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

Catalog Number 03666794001

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).

Event Description

The customer complained of an issue with their coaguchek xs meter that may impact the interpretation of their results.The customer initially stated that their meter would not turn on and that they heard a beeping sound.After replacing the batteries, the meter displayed an "error 8" alarm message, which indicates an error occurred during the internal diagnostic testing of the meter.The customer tried turning on the meter again and was able to enter the set mode of the meter.The meter then turned itself off and powered back only to display missing segments from the three 8's in the results portion of the meter display.This could affect the interpretation of results.The screen appeared to be blurry and several beeps were heard.There was no allegation of erroneous results or an adverse event.The customer stated that the there were no signs of moisture or debris inside the battery compartment and that the meter had not been cleaned prior to receiving the "error 8" alarm.The meter was requested to be returned for investigation.

Manufacturer Narrative

The meter was returned for investigation.Upon investigation of the returned meter, conductive rubber was found to be improperly adjusted.Medwatch fields 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7649798
• MDR Text Key: 113021177
• Report Number: 1823260-2018-02116
• 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
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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
• Date Returned to Manufacturer: 07/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2018
• 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