MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 GROWTH HORMONE (HGH); RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The customer obtained discordant low results for one patient with immulite 2000 xpi growth hormone (hgh), lot 235.The initial result was reported and questioned by the physician.The sample was retested on a different day and the result was low.The sample was sent to another laboratory, tested with an alternate method and a result of 53.3 ng/ml was obtained.This higher result was in line with physician´s expectations.A corrected report was issued.There are no allegations of patient intervention or adverse health consequences due to the discordant hgc results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report discordant low results for one patient with immulite 2000 xpi growth hormone (hgh), lot 235.The sample was sent to another laboratory, tested with an alternate method and a higher result was obtained, which was in line with physician´s expectations.Patient historical data, performed on a different alternate test method, was also higher than the immulite 2000 xpi results.The customer performed troubleshooting using autodilution.Diluted result was invalid.Neat result was low.Adjustment and controls were in range on days of testing.The limitations section of the instructions for use states: "patients on hgh therapy may develop human antibodies to hgh that will interfere in the assay and cause falsely low values." "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays." "samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result.These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur." "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.

Manufacturer Narrative

Siemens filed mdr 1219913-2023-00139 initial report on 2023-07-19.Additional information ¿ 2023-07-26.Siemens concluded investigation for an outside of the united states customer observation of immulite 2000 xpi growth hormone (hgh), lot 235, discordant low results for one patient vs results with alternate methods.The investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on review of customer quality control (qc) which showed recovery within acceptable ranges and no issues were observed with other patient samples.Assessment of instrument performance included a review of qc within acceptable limits and low sample result is reproducible.Based on the available information, a sample specific interferent cannot be ruled out as the cause of the discordant result.The limitations section of the instructions for use states, "patients on hgh therapy may develop human antibodies to hgh that will interfere in the assay and cause falsely low values." return of the patient sample for further investigation was not carried out because the customer performed dilutions and heterophilic blocking tube (hbt) testing on site.Based on the available information, a product performance issue has not been identified.Customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2023-00140 supplemental 1 report was filed for the same event.

• Brand Name: IMMULITE 2000 GROWTH HORMONE (HGH)
• Type of Device: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17353940
• MDR Text Key: 319720922
• Report Number: 1219913-2023-00139
• Device Sequence Number: 1
• Product Code: CFL
• UDI-Device Identifier: 00630414961552
• UDI-Public: 00630414961552
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10381451
• Device Lot Number: 235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male