MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM RUBELLA IGG (RUB G); ATELLICA IM RUB G

Model Number 10995670

Device Problem False Positive Result (1227)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the us customer observed false reactive (positive) atellica im rubella igg (rub g) result from a sample that was considered discordant on comparison with the repeat results from the same sample.Interpretation of results of the instructions for use (ifu) states the following: " results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Event Description

Customer observed false reactive (positive) atellica im rubella igg (rub g) result from a sample that was considered discordant upon comparison with repeat results from the same sample.The previous result for the patient was nonreactive (negative).Results were not reported to the physician.There were no reports that treatment was altered or postponed or adverse health consequences due to the false reactive atellica im rub g result.

Manufacturer Narrative

Mdr 1219913-2022-00051 was filed on february 11, 2022.Additional information - april 15, 2022: an outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report a false reactive (positive) atellica im rubella igg (rub g) result from a sample that was considered discordant upon comparison with repeat results from the same sample.The previous result for the patient was nonreactive (negative).The sample was repeated post re-centrifugation and the result was equivocal on the same and an alternate atellica im system with rub g lot 231.The customer reported that calibration was valid and quality control results were within insert ranges, but data was not provided.Siemens reviewed system sample and reagent trace files and there was no indication of a possible issue that could cause the initial false positive result.Pre-analytical factors and/or sample handling leading to particulate matter cannot be ruled out as a probable cause agent of the non-reproducible initial false positive result.Based on the information provided, no product problem has been identified and atellica im rub g lot 231 is performing as intended.The customer is operational, and no further action is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM RUBELLA IGG (RUB G)
• Type of Device: ATELLICA IM RUB G
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; walpole, MA 02032 ; 7372808688
• MDR Report Key: 13513415
• MDR Text Key: 288183567
• Report Number: 1219913-2022-00051
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 00630414600529
• UDI-Public: 00630414600529
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K003412
• 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,Followup
• Report Date: 05/10/2022

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: 02/01/2022
• Device Model Number: 10995670
• Device Catalogue Number: 10995670
• Device Lot Number: 231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 05/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female