MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI GROWTH FACTOR-1 (IGF-1); RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Model Number	11128543
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted siemens to report observations of imprecision with immulite 2000 xpi growth factor-1 (igf-1) that caused discordance between initial and repeat test results.Patient samples were tested and the results were reported to physician(s), who questioned the results.The samples were retested on the same day and results were lower.Corrected reports were issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant igf-1 results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report observations of imprecision with immulite 2000 xpi growth factor-1 (igf-1) that caused discordance between initial and repeat test results.Siemens healthcare diagnostics is investigating.The limitations section of the 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.".
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00457 initial report on 2021-10-01.Additional information - 2021-10-01.Siemens has concluded the investigation for observations of imprecise immulite 2000 xpi growth factor-1 (igf-1) initial patient results that were considered discordant when compared to repeat results.Siemens customer service engineer (cse) verified the dispense of the water and substrate pump volumes were within specification.The cse verified the wash station was clean and the probe angle of the sample and reagent probe are good.The watertest was performed and within specification.The cse ran calibrations and controls and all passed.The cse ran precision test for igf-1 using 20 replicates and the results were in acceptable range.While there is insufficient information to determine the cause of the imprecise initial patient results , siemens cannot rule out pre-analytical factors or sample issue.Based on the investigation, no product problem was identified.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated based on the investigation results.

• Brand Name: IMMULITE 2000 XPI GROWTH FACTOR-1 (IGF-1)
• Common Device Name: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 12565448
• Report Number: 1219913-2021-00457
• Device Sequence Number: 14275134
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: 00630414601236
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 11/09/2021

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: 09/30/2021
• Device Model Number: 11128543
• Device Catalogue Number: 11128543
• Device Lot Number: 232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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