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

Catalog Number 04837738001

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2016

Event Type  malfunction  

Event Description

The information in this report is from a voluntary event report the customer submitted directly to fda.The manufacturer does not have any customer contact information.The customer complained of results displayed on the coaguchek xs meter with an unknown serial number with a "c" beneath the result.A fingerstick result was obtained on a patient in a physician office.The actual result was not provided.A staff person noted the small "c" below the result but was unable to find anything in the operator manual or the package insert addressing this.The customer called the manufacturer to determine the meaning of the "c" beneath the result.The customer was informed that the "c" result meant the result was invalid.The customer alleges that if they had not called to find out the result was invalid, the invalid result would have been reported and acted upon.No adverse event occurred.The manufacturer faxed the customer a letter dated 2011 explaining the factors that could cause the "c" to occur.The customer indicates they received their meter in 2015 and the user manual is dated 2013, however, the user manual had not been updated to reflect the advisory letter that was sent in 2011.The investigation by the manufacturer has determined that the instructions for the "c" flag issue are currently present in the coaguchek xs plus and coaguchek xs pro user manuals.The patient self testing coaguchek xs user manual has been updated with instructions regarding the "c" flag issue.The professional coaguchek xs user manual is currently being revised with instructions for the "c" flag issue.

• 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: 5876416
• MDR Text Key: 52291008
• Report Number: 1823260-2016-01173
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/15/2016

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: Health Professional
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/15/2016
• 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