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

Catalog Number 10309477

Device Problem Calibration Problem (2890)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

Customer was having trouble with chemistry tests being run on the analyzer.The fse arrived at the facility the same day and did repairs on the analyzer.The fse had to order a frost sensor and was going to return on 07/17/15 to finish the repairs on the analyzer.The siemens field service engineer (fse) put the atlas analyzer on through mode so that customer could use the uf 1000i but a sign was placed on the atlas not to use the instrument because repairs were still being done on the analyzer.Customer should not have run patient samples without running qc and when repairs were still being done on the analyzer.Customer stated that all urine samples had been discarded and were not rerun.Some of the patients were in the er and they had been discharged from the facility.No new samples were collected.Customer confirmed that there was no harm to patients due to this event.Customer indicated that analyzer had been repaired (new power supply cable circuit board and sampler probe assembly installed) and it's operational.The event is occurred due to an operator error.

Event Description

Customer reported that they run 7 patient samples when analyzer was in service by siemens field service engineer (fse) awaiting part.Customer indicated that calibration was performed but quality control was not run.There was no report of injury due to this event.

• Brand Name: CLINITEK ATLAS
• Type of Device: CT ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 4992704
• MDR Text Key: 25484447
• Report Number: 1217157-2015-00117
• Device Sequence Number: 1
• Product Code: KQO
• 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: company representative,user f
• Reporter Occupation: Medical Technologist
• Report Date: 07/17/2015

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: 10309477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1