MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI 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	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the observation of falsely depressed igf-i results obtained on patient samples on an immulite 2000 xpi instrument.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate immulite 2000 xpi instrument.The repeat results were higher than the erroneous results.The repeat results were 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 depressed igf-i results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report falsely depressed igf-i results that were obtained on patient samples on an immulite 2000 xpi instrument.Quality controls (qcs) recovered within ranges and adjustment was valid on the day of the event.There were no error messages in the instrument event log that would suggest a mechanical error.It was not possible to perform a visual inspection of the samples.Prior to the event date, on 13-sep-2024, it was observed that the sample probe presented an inadequate dispensing angle.The customer service engineer (cse) verified that the equipment was paused and, without error, the equipment was resumed for routine use.Routine monitoring was carried out.There were no errors during the evaluation.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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2024-00441 on 21-oct-2024.Additional information 17-dec-2024: immulite 2000 igf-i kit lot 316 is expired and is no longer in use by the customer.Prior to the event date, on 13-sep-2024, it was observed that the sample probe presented an inadequate dispensing angle.A siemens customer service engineer verified that the equipment was paused and without error, the equipment was resumed for routine use.Routine monitoring was carried out and there were no errors during the evaluation.The performance is now acceptable.It is not possible to rule out the possibility that pre-analytical factors are responsible for the divergence of the samples results however, visual inspection of these samples was not able to be performed.Siemens provided the following conclusions: no systemic issue has been found with the samples.No issues have been observed with bubbles in the reagent or samples.The reagent was very low for one sample tested, but no errors such as level sensing, were observed therefore it is most likely not related to the discordant result.A probe wash empty error was observed during the period of time when patient samples were tested.This error may have contributed to the discordant results observed with patient samples run after that time, but there were also discordant results observed with patient samples run before this error occurred so this would not explain all discordant results.There have been no issues with quality controls and the issue is limited to sporadic samples.This indicates that the issue is most likely due to pre-analytical factors.Siemens recommends that the sample handling be checked at the customer's site and to ensure that instrument maintenance is up to date.The customer is operational and the issue is resolved via routine troubleshooting.The immulite 2000 igf-i kit lot 316 performed 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 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: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 20493732
• Report Number: 1219913-2024-00441
• Device Sequence Number: 19877336
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: (01)00630414601236(10)316(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): Y
• 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): 12/20/2024

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: 316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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 Sex: Unknown