MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG); HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY

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	07/23/2022
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 elevated immulite 2000 xpi hcg results for a patient sample compared to repeat results using the same instrument and an alternate method (atellica im analyzer).Quality control (qc) was in range at the time of testing.The limitations section of the instructions for use states: "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 falsely elevated immulite 2000 xpi human chorionic gonadotropin (hcg) results on one patient sample.The sample was retested on the same day using the same instrument and an alternate method (atellica im analyzer) and results were lower.On a different day, the customer retested the same sample with immulite 2000 xpi hcg and the alternate method and all results were low.A new sample was drawn and tested a few days later with immulite 2000 xpi hcg and the alternate method and results were low.The initial elevated results were not reported to the physician(s).The lower repeat results were believed to be correct and were reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated hcg results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2022-00237 initial report on 2022-08-18.Additional information: 2022-10-13.Siemens evaluated the sample level sense data and the reagent level sense data for the sample in question (sample id: (b)(6).Evaluation of the sample and reagent level sense data does not show any aberrant level sensing that would indicate a liquid level sensing problem.Evaluation of the instrument error log does not indicate any errors for the date of the event.Evaluation of the instrument support data does not indicate a conclusive probable cause as to what may have contributed to the questionably high hcg patient sample results, from an instrument perspective.Additional information: 2022-10-28.Siemens has concluded the investigation for an outside of the united states (ous) customer observation of falsely elevated discordant results on a patient sample tested with immulite 2000 xpi human chorionic gonadotropin (hcg) kit lot: 472, compared to lower retest results.The patient sample initially resulted 22 miu/ml on (b)(6) 2022 and 25.3 miu/ml when repeated on the same system less than an hour later.This was the only patient sample tested on the immulite 2000 xpi on this date.Bio-rad immunoassay plus qc (control lot: 85280) was tested on this day and was in range.The sample was repeated on an atellica im with a lower result of 0.6 miu/ml.The sample was retested for hcg on (b)(6) 2022 on both the immulite 2000 xpi and atellica im instruments and the results were <1 miu/ml.The lower repeat values were reported as being clinically accurate.Another draw from the same patient resulted <1 miu/ml on both platforms.Instrument files were received for this event and have been reviewed by siemens.Evaluation of the sample and reagent level sense data does not show any aberrant level sensing that would indicate a liquid level sensing problem.Evaluation of the instrument error log does not indicate any errors for the date of the event.Evaluation of the instrument support data does not indicate a conclusive probable cause as to what may have contributed to the questionably high hcg patient sample results, from an instrument perspective.Siemens is unable to rule out preanalytical variables and/or sample handling as the cause of the discordant results.Based on the investigation results, immulite 2000 xpi hcg kit lot: 472 is performing as intended.A potential product performance 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: HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 15252602
• Report Number: 1219913-2022-00237
• Device Sequence Number: 14905160
• 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): 11/07/2022

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: 07/25/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/07/2022
• 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 Age: 40 YR
• Patient Sex: Female