MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA DATA MANAGER

Model Number ATELLICA DATA MANAGER

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

The customer¿s practice of using patients¿ dates of birth as a patient identifiers when patient identifiers do not exist on the laboratory information system (lis) contributed to the reuse of patient identifiers on the atellica data manager.When two patients have the same date of birth, the atellica data manager updates the previous patient¿s demographics associated to the patient identifier to the demographics of the latter patient.Section b6 delineates an example in which two patients share the same date of birth; in the example the customer provided, specific identifiers were also available for the individual specimens.There were no known reports of patient intervention or adverse health consequence due to this event.

Manufacturer Narrative

An outside of united states (ous) customer contacted siemens to request guidance to prevent patient¿s demographics from being overwritten when the customer reuses patient identifiers on the atellica data manager.Siemens determined that the customer practice of reusing patient identifier does not met the laboratory information system (lis) requirements of atellica data manager described in the atellica data manager lis interface guide.The interface guide indicates ¿the atellica dm software is designed to operate with unique patient identifiers across all connected lis.As the lis is considered the master system from which the most current data originates, the atellica dm software always accepts updates to patient records from the originating lis.As such, every patient demographic update that is downloaded from the lis to the atellica dm software must be identified by a unique patient id that references the same physical patient.If you reuse a patient id to reference another physical patient, patient demographic updates downloaded from the lis overwrite the original patient details associated with this patient id.An erroneous mix of details that pertain to another physical patient would coexist in the same record of the atellica data manager database with unrelated details that pertain to the original physical patient.Do not re-use patient ids¿.The cause of the event is a use error.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA DATA MANAGER
• Type of Device: ATELLICA DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration #: 8020888; swords, co., dublin ; EI
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 17280521
• MDR Text Key: 318791188
• Report Number: 2432235-2023-00209
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2023

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 Model Number: ATELLICA DATA MANAGER
• Device Catalogue Number: 11314429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/07/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 33 YR