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

Catalog Number 10309477

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/20/2014

Event Type  No Answer Provided  

Event Description

Customer reported that clinician questioned leukocytre and nitrite results on instrument.

Manufacturer Narrative

Customer indicated that they did not question negative nitrite and leukocytes results on instrument.Customer indicated that they felt that there was no issue with the instrument.Customer indicated that all quality control had been within acceptable range for all testing events and they had verified samples with elevated specific gravity and 'cloudy/turbid' samples via manual method, which correlated with the atlas results.Siemens field service engineer replaced and tested new sample syringe asy.And reviewed system operation with customer.System is operational.

Manufacturer Narrative

Customer indicated that the lab manager and medical director did not have the patient test information.Customer indicated that they were informed by lab management and the medical director that an emergency department physician questioned the atlas results on a particular patient.The patient was not admitted at the facility, went home and then was admitted to a different facility.It is not known if any additional testing was performed on this patient, since the patient identity is unknown, and the emergency department physician was unable to answer any questions.As a result, the customer was not able to retrieve any further urine chemistry data, including specific gravity.The customer indicated that they were satisfied with the atlas performance, and there had not been further issues of results being questioned.

• 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: 4309688
• MDR Text Key: 5194693
• Report Number: 1217157-2014-00186
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

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: Other
• Device Catalogue Number: 10309477
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1