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

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	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated hcg result was obtained on a patient sample on an immulite 2000 xpi instrument.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the same instrument three days later.The repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated hcg result.
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted a siemens customer care center to report a falsely elevated hcg result that was obtained on a patient sample on an immulite 2000 xpi instrument.Per the limitations section in the immulite 2000 hcg instructions for use (ifu): "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 initial mdr 1219913-2024-00359 on 09-jul-2024.Additional information 25-jul-2024: siemens investigation included an assessment of the following: return of the patient sample for further investigation is not possible due to local regulations.Requested information about sample handling, main database, error logs, and spy files were not provided.Additionally, siemens requested adjustment and quality control (qc) data, a printout or screenshot of the sample measurement and if any service was performed.No information can be provided.A query showed no similar escalations relating to immulite 2000 xpi hcg and kit lot 480.Customers were sent urgent field safety notice (ufsn) imc22-04 human chorionic gonadotropin (hcg) potential carryover from high samples and should be following the repeat instructions for samples between 2.5 and 750 miu/ml.Based on the available information, the cause of the discordant result is inconclusive.Additional information was requested from the customer and was not provided by the customer.Based on the limited information provided, further evaluation is not possible.The immulite 2000 xpi hcg kit lot 480 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 HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration #: 3002806944; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 19702941
• Report Number: 1219913-2024-00359
• Device Sequence Number: 3641842
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: (01)00630414961149(10)480(17)20241231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 07/30/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10381194
• Device Lot Number: 480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• 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: 30 YR
• Patient Sex: Female