MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 1000 HCG; IMMULITE 1000 HUMAN CHORIONIC GONADOTROPIN (HCG)

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	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer indicated there was a discrepant result on one patient sample on an immulite 1000 analyzer, serial number (b)(4), when using immulite 1000 human chorionic gonadotropin (hcg) reagent lot 511.The discordant result was not reported to the physician(s).The sample was repeated on the same analyzer and the repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) to report an immulite 1000 human chorionic gonadotropin (hcg) result for one patient that was discordant when compared to repeat testing on the same immulite 1000 analyzer.The expected results were based on historical data and clinical picture of the patient.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.
Additional Manufacturer Narrative
Siemens filed the initital mdr on february 14, 2023.Additional information february 24, 2023: the customer reported a falsely elevated discordant patient result on the immulite 1000 hcg assay with kit lot 511.On (b)(6) 2023, a sample from a patient in early pregnancy resulted 622 iu/l on the immulite 1000 hcg assay.This result seemed high based on the patients prior hcg value.They decided to repeat the sample initially tested on (b)(6) 2023 (without being recentrifuged) and it resulted lower at 197 iu/l.The lower repeat result was aligned with clinical expectation.Hcg quality control results were acceptable on day of this event.Service was dispatched and a total service call was performed but no mechanical issues were noted.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on qc recovery being acceptable and no issues were reported with other patient samples tested.Based on the available information, the cause of the discordant result is consistent with a sample integrity issue.The customer is operational and has had no further discordant results.A potential product issue has not been identified.The immulite 1000 hcg kit lot 511 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 1000 HCG
• Common Device Name: IMMULITE 1000 HUMAN CHORIONIC GONADOTROPIN (HCG)
• 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 ; 3395774748
• MDR Report Key: 16371136
• Report Number: 2432235-2023-00067
• Device Sequence Number: 17984546
• Product Code: DHA
• UDI-Device Identifier: 00630414963716
• UDI-Public: 00630414963716
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K990222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381161
• Device Lot Number: 511
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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