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	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating this event.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." mdr 1219913-2021-00394 was filed for results from the same sample generated on (b)(6) 2021.
Event or Problem Description
The customer observed elevated immulite 2000 xpi human chorionic gonadotropin (hcg) results for a patient sample compared to repeat results using the immulite 2000 xpi human chorionic gonadotropin (hcg) assay, an alternate method and the clinical picture.The initial results were reported to and questioned by 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 results.
Additional Manufacturer Narrative
Mdr 1219913-2021-00391 was filed on july 26, 2021.August 12, 2021 - additional information.Qc was in range at the time of the event.Siemens confirmed there was no malfunction of the system, and that the system was not serviced by a third party.Section d8 was updated to reflect this.Siemens continues to investigate.Mdr 1219913-2021-00394 supplemental 1 was filed for a result from the same sample generated on june 25, 2021.
Additional Manufacturer Narrative
Mdr 1219913-2021-00391 was filed on july 26, 2021.Mdr 1219913-2021-00391 supplemental 1 was filed on september 3, 2021.February 1, 2022 - additional information.An outside of the united states (ous) customer contacted siemens to report a falsely high and discordant patient result on the immulite xpi 2000 hcg assay with reagent lot 463.The customers hcg adjustment and qc results were acceptable.Inspection of the sample did not identify any issues with fibrin, hemolysis or lipemia.Service was dispatched for this event but they found no instrument issues.Siemens requested spy files and the main database but they were not provided after multiple requests.Siemens performed an investigation with customer returned and acquired patient samples and continues to investigate.Mdr 1219913-2021-00394 supplemental 2 was filed for the same incident.
Additional Manufacturer Narrative
Mdr 1219913-2021-00391 was filed on july 26, 2021.Mdr 1219913-2021-00391 supplemental 1 was filed on september 3, 2021.Mdr 1219913-2021-00391 supplemental 2 was filed on february 21, 2021.On february 22, 2022 - additional information siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated hcg results due to sample carryover.This can be observed when a sample is assayed for hcg immediately after an undiluted sample with a hcg value of >5000 miu/ml.This issue impacts serum and urine patient samples, as well as quality control samples and adjustors.The effect of carryover varies based on the concentration of the high hcg sample.Starting (b)(6) 2022 an urgent medical device correction (umdc, letter imc22-04.A.Us) was sent to us customers, and an urgent field safety notice (ufsn, letter imc22-04.A.Ous) was sent to outside the us (ous).The umdc and ufsn explain the potential for carryover from high hcg samples into the next sample assayed for hcg on the immulite 2000/immulite 2000 xpi, and provides instructions to the customers.In section h6, type of investigation, investigation finding, and investigation conclusion codes were updated based on additional information.Section h7 was updated to indicate recall and section h9 was updated to include the correction/ removal reporting number.Mdr 1219913-2021-00394 supplemental 3 was filed for the same incident.

• 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 LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 12225545
• Report Number: 1219913-2021-00391
• Device Sequence Number: 4377624
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: 00630414961149
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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,Followup,Followup
• Report Date (Section B): 03/14/2022

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381194
• Device Lot Number: 463
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 02/01/2022; 02/22/2022
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 09/03/2021; 02/21/2022; 03/15/2022
• Date Device Manufactured: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-03/04/2022-002-C
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female