MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS; CT ADVANTUS

Catalog Number 10636672

Device Problems Data Problem (3196); Patient Data Problem (3197)

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

Event Date 05/10/2014

Event Type  malfunction  

Event Description

Customer was running a load list on instrument and sample #3 results downloaded with patient #2 information.There was no report of injury due to this event.

Manufacturer Narrative

Customer was not waiting to enter entire patient list before putting in the test strip, user error.Customer has been instructed during technical support call to enter each set of patient/sample information and not place the test strips until load list is complete.Instrument is functioning correctly.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CT ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): KIMBALL ELECRONICS POLAND SP.Z O.O; ul. pozenanska 1/c; tarnowo podgorne 62-0 80; PL 62-080
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3898193
• MDR Text Key: 15107359
• Report Number: 1217157-2014-00090
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/06/2014

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: Medical Technologist
• Device Catalogue Number: 10636672
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1