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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer indicated there were discordant results on two patient samples on an immulite 2000 xpi analyzer, serial number (b)(4), using immulite 2000 human chorionic gonadotropin (hcg) reagent lot 472.The discordant results were not reported to the physician(s).The samples were repeated two more times on the same analyzer on the same day.For sid (b)(6), the repeat results were reported to the physician(s).For sid (b)(6), it is not known which repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report immulite 2000 human chorionic gonadotropin (hcg) results for two patients that were discordant when compared to repeat testing on the same immulite 2000 xpi analyzer.The expected patients results were based on historical data, results from another non-siemens system, and results from hcg rapid tests.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 2432235-2023-00033 on january 23, 2023.Additional information april 19, 2023: the immulite 2000 xpi system was checked by a siemens field service representative and no issues were identified.All other assays being run on this system were performing acceptably.Hcg precision was verified by testing samples in multiple replicates.Siemens has completed review of the system files provided.The review did not indicate that there was any sample or reagent level sense issues.Review of the error messages showed that no errors occurred during the aspiration of the two sample id's.Siemens cannot rule out pre-analytical factors or sample issues.A potential product issue has not been identified.The immulite 2000 human chorionic gonadotropin (hcg) reagent lot 472 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 2000 XPI HUMAN CHORIONIC GONADOTROPIN
• Common Device Name: IMMULITE 2000 HUMAN CHORIONIC GONADOTROPIN
• 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 ; 3392069063
• MDR Report Key: 16223550
• Report Number: 2432235-2023-00033
• Device Sequence Number: 12080373
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 04/25/2023

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 472
• 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: 12/29/2022
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 04/25/2023
• 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