MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3); IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3)

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

The customer observed discordant low patient sample results when using immulite 2000 unconjugated estriol (ue3) kit lot 494, in comparison to results obtained when patient samples were sent to another laboratory and tested with kit lot 495.The initial results with kit lot 494 were not reported to the physician(s).There are no known reports of adverse health consequences.

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 unconjugated estriol kit lot 494, in comparison to results obtained when patient samples were sent to another laboratory and tested with kit lot 495.The limitations section of the immulite 2000 unconjugated estriol 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.Mdr 2432235-2023-00051, mdr 2432235-2023-00052, and mdr 2432235-2023-00053 were also filed for a similar incident with immulite 2000 ue3 kit lot 496 on (b)(6) 2023.Mdr 2432235-2023-00054, mdr 2432235-2023-00056, and mdr 2432235-2023-00057 were also filed for a similar incident with immulite 2000 ue3 kit lot 494 on (b)(6) 2023.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00055 on 10-februrary-2023.Additional information 22-march-2023: siemens has completed the investigation into low immulite 2000 unconjugated estriol (ue3) results obtained for four samples.Siemens has been asked to provide a technical evaluation of this case where two samples reported <0.07 ng/ml on kit lot 494 but 0.105 ng/ml and 0.226 ng/ml on kit lot 495, and two samples reported <0.07 ng/ml which were considered low by the customer though no repeat results >0.07 ng/ml were obtained for these two samples.For ue3 the median values for weeks 26 and up are anywhere from 4 to 12 ng/ml.The values of <0.07, 0.105, and 0.226 ng/ml are near or at the lower part of the reporting range.Siemens requested, three times, what the multiple of the median (mom) values were however customer did not respond with any follow-up information.The difference between 0.07, 0.105, and 0.226 ng/ml could be due to shipping the sample.Siemens requested samples for testing however no response was received.Reviewed in-house data and a set of ue3 patient panels are run at every kit release.Kit lots 494, 495, 496 were reviewed and all samples met the expected values.Siemens is unable to determine a potential root cause as no further information was provided.Siemens has no data suggesting mom values would be different.No further discrepant's reported.The immulite 2000 unconjugated estriol (ue3) kit lot 494 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.Note: in section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3)
• Type of Device: IMMULITE 2000 UNCONJUGATED ESTRIOL (UE3)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; 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 ave; tarrytown, NY 10591 ; 3392069063
• MDR Report Key: 16351452
• MDR Text Key: 309406557
• Report Number: 2432235-2023-00055
• Device Sequence Number: 1
• Product Code: CGI
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381192
• Device Lot Number: 494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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