MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PRO KIT INTERNATIONAL; COAGUCHEK ® XS SYSTEM

Catalog Number 05530199190

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The sales representative indicated that the coaguchek xs pro meter with serial number (b)(4) incorrectly identified patient ids.The meter is connected to an unspecified it system.It was noted that an old patient list had been uploaded and when a patient bar code was scanned, an incorrect patient with another patient's id was identified.The issue happened twice with different ids.The sales representative observed one.The patient results were not reported because the issue was noticed by the user.No adverse event occurred.It was noted that neither the patient bar codes nor any other information about the it system used can be obtained.The suspect product was requested for investigation.

Manufacturer Narrative

The customer will not be returning the meter as they believe they identified the root cause of the issue.The customer had pre-loaded an old patient list that was saved in the meter but was not the same list as the newly scanned patient ids.The pre-loaded, old patient ids should have been deleted prior to introducing new patient ids.

Manufacturer Narrative

It was also noted that when the patient id was scanned, the user pressed the id button at the same time which automatically causes a patient id mismatch.

• Brand Name: COAGUCHEK XS PRO KIT INTERNATIONAL
• Type of Device: COAGUCHEK ® XS SYSTEM
• 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: 5844162
• MDR Text Key: 51138549
• Report Number: 1823260-2016-01111
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05530199190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• 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