MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 IGF-I; RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens regional support center to report a falsely depressed igf-i result obtained on an immulite 2000 instrument.Quality control was within acceptable ranges on the date of testing.The limitations section of the immulite 2000 igf-i instructions for use (ifu) 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 is investigating.
Event or Problem Description
The customer contacted siemens and reported a falsely depressed insulin-like growth factor-1 (igf-1) result was obtained on an immulite 2000 system.The sample was repeated on the same system and the repeat result, considered correct, was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous igf-1 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2024-00422 on 23-sep-2024.Additional information 18-oct-2024: siemens evaluated this issue and provided the following conclusion: based on a review of the data, adjustments and quality control were valid on the date of testing and water tests were within specifications.The initial results were measured with an aliquot of diluent that had been onboard for approximately 36 hours.After fresh igf sample diluent was placed on the system, the samples repeated within expected values.This issue was resolved with routine troubleshooting.Immulite 2000 insulin-like growth factor i (igf-i) lot 313 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000 IGF-I
• Common Device Name: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• 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: jennifer cacace ; 511 benedict ave; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 20281232
• Report Number: 1219913-2024-00422
• Device Sequence Number: 7546017
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: (01)00630414601236(10)313(17)241130
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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): 11/05/2024

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 11128543
• Device Lot Number: 313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 05/21/2024
• 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: 11 YR
• Patient Sex: Male