MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE/IMMULITE 1000 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	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated hcg result was obtained on a patient sample on an immulite 1000 instrument.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated using an alternate platform.The repeat result was negative and was in alignment with the clinical picture of the patient.The repeat result was reported, as the correct result, to the physician(s).There are no allegations of patient harm, changes in treatment or delays in diagnosis in association with the observed erroneous result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens regional support center (rsc) to report a falsely elevated hcg result obtained on a patient sample on an immulite 1000 instrument which was discordant relative to repeat testing using an alternate platform.The assay's instructions for use (fu) states the following under limitations: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.[see boscato lm, stuart mc.Heterophilic antibodies: a problem for all immunoassays.Clin chem 1988:34: 27-33.] samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result.These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur.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 1219913-2024-000286 on 10-apr-2024.Additional information 25-jul-2024: siemens evaluated this issue and provided the following conclusion: based on a review of the adjustment data, error logs and database, there is no indication of an instrument issue that would have caused the elevated results observed by the customer.Water contamination cannot be ruled out as a possible cause nor can preanalytical variables.Immulite 1000 hcg lot 516 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/IMMULITE 1000 HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration #: 3002806944; 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: jennifer cacace ; 333 coney st.; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 19080955
• Report Number: 1219913-2024-00286
• Device Sequence Number: 5897275
• Product Code: DHA
• UDI-Device Identifier: 00630414963716
• UDI-Public: 00630414963716
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10381161
• Device Lot Number: 0516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown