MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC CLINITEK ATLAS ANALYZER; CT ATLAS

Catalog Number 10309478

Device Problem False Positive Result (1227)

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

Event Date 04/21/2014

Event Type  malfunction  

Event Description

Customer received false positives for urobilinogen on two patient samples.There was no report of injury due to this event.

Manufacturer Narrative

Siemens field service engineer(fse) went on site and checked the instrument.The instrument was having trouble calibrating and was stripping pads of the reagent roll.During fse inspection, reagent dispense mechanism was not locked properly into place which caused the pads to dispense improperly and strip pads off.Fse aligned the mechanism properly to which instrument passed calibration and controls.Instrument is operational on fse departure.

Manufacturer Narrative

(b)(4).

• Brand Name: CLINITEK ATLAS ANALYZER
• Type of Device: CT ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SPARTON MEDICAL; 22740 lunn road; cleveland OH 44149
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3825108
• MDR Text Key: 4447008
• Report Number: 1217157-2014-00073
• Device Sequence Number: 1
• Product Code: CDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

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: Health Professional
• Device Catalogue Number: 10309478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1