MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG); IMMULITE 2000 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	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed an elevated immulite 2000 xpi human chorionic gonadotropin (hcg) result for a patient sample compared to repeat results using the same instrument and an atellica im 1600 analyzer.The initial result was not reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated immulite 2000 xpi hcg result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report an elevated immulite 2000 xpi hcg result that was considered discordant compared to repeat results with the immulite 2000 xpi analyzer and an alternate method (atellica im 1600 analyzer).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 continues to investigate.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2022-00241 initial report on 2022-08-09.Additional information - 2022-09-23.Siemens concluded the investigation for an outside of the united states (ous) customer observation of a falsely elevated non-reproducible patient result on the immulite 2000 xpi human chorionic gonadotropin (hcg) assay with lot 472 that was considered discordant compared to repeat results with the immulite 2000 xpi analyzer and an alternate method (atellica im 1600 analyzer).On (b)(6) 2022, a patient sample initially resulted 18 miu/ml and then <1.0 miu/ml when repeated on both platforms.The lower repeat value of <1.0 miu/ml was reported as being accurate.Biorad immunoassay plus qc lot 85280 was in range on the day of this event.The customer tested seven hcg samples on (b)(6) 2022, and all samples repeated acceptably, except the initial discordant sample.Siemens reviewed the instrument spyfile for this event, which only contained the single sample from the (b)(6) 2022 testing (started at 3:16 pm and resulted at 3:53 pm).Data evaluation, from a sample level sense perspective, is inconclusive as there is only a single sample so there is nothing to compare delta values with a repeat sample.Reagent level sense data appears to be consistent and does not represent any concerns.Evaluation of the provided error log does not indicate any errors at the time of the this particular sample result.Siemens cannot determine the cause of this discordant result.Contributing factors, such as sample integrity and/or sample handling cannot be ruled out.Based on the results of the investigation, return of the patient sample is not warranted.A potential product issue has not been identified.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG)
• Common Device Name: IMMULITE 2000 HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd ll55 4el ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15195153
• Report Number: 1219913-2022-00241
• Device Sequence Number: 12237768
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: 00630414961149
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381194
• Device Lot Number: 472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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