MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens regional support center to report falsely elevated hcg results that were obtained on a patient sample on an immulite 2000 xpi instrument.Quality control (qc) recovered within acceptable ranges on the dates of testing.Siemens evaluated the issue and provided the following conclusion: as stated in the assay's instructions for use (ifu), hcg sample diluent (l2cgz, l2cgz4) is for the on-board dilution of high samples.Diluting samples that are negative or below the linearity of the assay would apply a dilution factor to nonspecific background counts which could cause a negative response to appear positive.According to the data provided, adjustment was found complete and qc within range.The assay and system are performing as expected.Immulite 2000 hcg lot 481 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.
Event or Problem Description
The customer reported falsely elevated hcg results were obtained on a diluted patient sample on an immulite 2000 xpi instrument.The initial erroneous result was reported to the physician(s) who questioned the result.Historic results for the patient were < 0.1 miu/ml.The sample was repeated neat and diluted.The neat result was lower than the initial result and was reported as the correct result to the physician(s).The repeat diluted result remained falsely elevated and was not reported.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated hcg results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2024-00497 on 11-dec-2024.Additional information: mdr 1219913-2024-00498 was filed for event date 14-nov-2024.

• Brand Name: IMMULITE 2000 HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration #: 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 20904527
• Report Number: 1219913-2024-00497
• Device Sequence Number: 4120057
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: (01)00630414961132(10)481(17)250228
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K990222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 12/12/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 12/12/2024
• Date Device Manufactured: 05/09/2024
• 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 Age: 10 YR
• Patient Sex: Female