MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 HCG ASSAY; 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	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports observation of a discordant elevated patient result for a female patient sample when running immulite 2000 xpi, hcg assay lot 476.The initial result was reported to the physician(s) who did not question the result.The same sample was repeated on the same immulite 2000 xpi instrument and a lower result was obtained.The customer service engineer (cse) replaced the centrifuge station, vacuum pump, water trap tubes and both pipettes after reviewing the list of errors.The instrument was decontaminated twice, once with diluted bleach and once with caustic soda and left under observation.The limitations section of the immulite 2000 hcg 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 healthcare diagnostics is investigating.
Event or Problem Description
The customer reports observation of a discordant elevated patient result for a female patient sample when running immulite 2000 xpi, hcg assay lot 476.The initial result was reported to the physician(s) who did not question the result.The same sample was repeated on the same immulite 2000 xpi instrument and a lower result was obtained.There are no allegations of patient harm, changes in treatment, or delay in diagnosis in association with the observed discordant hcg result.
Additional Manufacturer Narrative
Initial mdr 1219913-2023-00177 was filed on 25-aug-2023.Correction: section d3: manufacturer name and address has been updated.Additional information - 20-nov-2023: the customer reported a falsely elevated discordant result on the immulite 2000 xpi hcg assay with kit lot 476.On (b)(6) 2023, a 13-year-old female patient initially resulted 81.7 u/l and when repeated on the immulite 2000 and an alternate method the results were <1 u/l.In both cases, the lower repeat results were correct.Troubleshooting by the customer included performing a water test which was negative for contamination.Service was dispatched and preventively replaced the centrifuge station, vacuum pump, water trap tubes, both pipettes and decontaminated the system.These are considered standard service actions for an issue of this nature.Siemens is unable to rule out preanalytical handling including possible presence of fibrin as the cause of the falsely elevated results.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: IMMULITE 2000 HCG ASSAY
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd ll55 4el NY ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd ll55 4el ; UK
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17622459
• Report Number: 1219913-2023-00177
• Device Sequence Number: 15339809
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• 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): 11/28/2023

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female