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

Catalog Number	11128543
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the observation of three erroneous falsely depressed patient results with insulin-like growth factor i (igf-i), lot number: 317 on an immulite® 2000 xpi immunoassay system, serial number: (b)(6).The falsely depressed patient results were reported to the physicians and were questioned.The samples were reprocessed on the other immulite 2000 xpi analyzer and one result was corrected sample: sample id (b)(6).There are no known reports of patient intervention or adverse health consequences due to the issue.
Additional Manufacturer Narrative
An outside the united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the observation of three erroneous falsely depressed patient results with insulin-like growth factor i (igf-i) lot 317 on an instrument is an immulite® 2000 xpi immunoassay system.Quality control (qc) did not recover within range when samples were initially tested.The qc on the alternate instrument used for reprocessing the samples qc was in range.Siemens is currently investigating the issue.
Additional Manufacturer Narrative
Mdr 1219913-2024-00442 was filed on 24-october-2024.Additional information - 12-november-2024: siemens reviewed the information provided by the customer.There were no instrument interventions that occurred when the depressed results were observed.Repeat igf-1 testing of samples prior to the elevated results showed no issues.Review of quality control (qc) indicated failures (values which were low out of range) were observed during the same time period as the discrepant results.The customer replaced the reagents with new packs from the same lot and performed a new adjustment.Qc came in range.The customer is operational.The issue was resolved by routine troubleshooting.

• Brand Name: IMMULITE 2000 HUMAN GROWTH HORMONE (IGF-I)
• Common Device Name: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED SIEMENS HEA; 3002806944; glyn rhonwy LL55 4EL; UK LL55 4EL
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 20508144
• Report Number: 1219913-2024-00442
• Device Sequence Number: 15433933
• Product Code: CFL
• UDI-Device Identifier: 00630414601236
• UDI-Public: (01)00630414601236(10)317(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): 11/22/2024

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 Catalogue Number: 11128543
• Device Lot Number: 317
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown