MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR RUBELLA G; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from the united states contacted siemens on 2023-09-05 due to observations of imprecision in calibration and quality control (qc) results for advia centaur rubella g (rub g), lot 246.Specifically, the customer noted imprecision for the level-1 control and repeatedly high cvs for calibration.Siemens service undertook troubleshooting with the customer, including a precision study.Service was sent to the customer site to perform checks and decontamination.Following the service intervention, the customer ran qc with acceptable results before and after successfully recalibrating the assay successfully on 2023-09-19.Patient samples were tested the same day, and one sample was observed to have produced an elevated (positive) rub g result which was discordant relative to alternate-method testing.Siemens was informed of the discordant observation on 2023-09-21.Siemens is investigating.

Event Description

The customer reported observation of a positive advia centaur rubella g (rub g) result which was discordant relative to alternate-method testing.The initial elevated result was not reported to the physician.The sample was sent to an external reference lab, and a negative result was returned.This result was accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

• Brand Name: ADVIA CENTAUR RUBELLA G
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA ; 5082985306
• MDR Report Key: 17831088
• MDR Text Key: 324440814
• Report Number: 2432235-2023-00261
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2023

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 Expiration Date: 03/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 09/28/2023
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female