MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 PROLACTIN

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant low patient sample results when using immulite 2000 prolactin kit lot 418, in comparison to repeat testing with kit lot 420.The limitations section of the instructions for use states the following: "for diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." siemens is investigating.
Event or Problem Description
The customer observed discordant low patient sample results when using immulite 2000 prolactin kit lot 418, in comparison to repeat testing with kit lot 420.The customer indicated that they were observing high slopes with kit lot 418 and failed calibrations, but reported patient results.The customer tested patient sample ra with kit lot 418 with an initial result of 11.4 ng/ml.This was reported to the physician(s) and was not questioned.The customer switched to kit lot 420 and repeated the same sample on the same instrument on lot 420 and the result was 22.4 ng/ml.A corrected report was not issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00379 on 08-december-2022.Additional information 16-december-2022: siemens has reviewed customer complaint for immulite 2000 prolactin (prl) assay for failed slopes on reagent lot 418.Slope was high at >1.8.Siemens initiated a study with prl lot 418 for failed slope adjustments.The outcome of the study indicated prl lot 418 is performing within assay slope specifications.No slope failures were generated.Customer has successfully been able to adjust prl lot 420 which rules out any instrument issue.Customer has moved to prl lot 420 with acceptable slope performance.Siemens is unable to verify assay performance as customer is not using commercial controls, only patient pool controls.Precision on the customer's patient pool controls was acceptable.Customer is operational.Siemens cannot rule out a site specific issue with reagent handling or deviation from recommended best practices for reagent handling and storage as contributing factors to the failed adjustments.The immulite 2000 prolactin (prl) kit lot 418 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 PROLACTIN
• Common Device Name: IMMULITE 2000 PROLACTIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer Contact: karen confort ; 511 benedict avenue; tarrytown, NY 10591 ; 3392069063
• MDR Report Key: 15945633
• Report Number: 2432235-2022-00379
• Device Sequence Number: 12363330
• Product Code: CFT
• UDI-Device Identifier: 00630414961934
• UDI-Public: 00630414961934
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K925846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381200
• Device Lot Number: 418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown