MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROLACTIN (PRL); PROLACTIN (PRL) IMMUNOASSAY,

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	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant low atellica im prolactin (prl) result compared to higher results when the sample was diluted.Siemens is investigating.The instructions for use (ifu) states the following in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Event or Problem Description
A false low atellica im prolactin (prl) result (neat) was obtained on a patient and the reported result was questioned by the physician(s).Based on the patient's clinical history, a higher prl result was expected.The customer performed serial dilution testing of the sample and the prl results increased as the dilution factor increased.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, low atellica im prolactin (prl) result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00211 initial report on 30-mar-2021 for a discordant low atellica im prolactin (prl) result compared to higher results when the sample was diluted.On 16-jun-2021 - additional information: siemens has completed the investigation.The customer obtained a low patient result perceived as being discordant on the atellica im prolactin (prl) assay.The sample recovered 0.87 ng/ml when tested neat.The sample was then diluted 1:2, 1:5, 1:20 and 1:100 because the customer suspected a potential hook effect.The prolactin values increased as the dilution factors increased with the 1:100 dilution resulting 39.72 ng/ml.Quality control (qc) and other patient samples were not affected.This issue only affected this patient sample.The atellica im prolactin instructions for use states that samples with prolactin levels as high as 30,000 ng/ml will assay greater than 200 ng/ml.Multi-diluent 1 is the recommended diluent for both on-board and manual dilutions.Dilution recovery is optimized for samples reading above the analytical measuring range.A potential hook effect can occur when the antigen concentration present in the sample gives an unexpectedly low result not matching the clinical picture.When a hook effect is suspected, the sample should be serially diluted.The result of the most diluted sample that falls within the assay measuring range (amr) should be multiplied by the appropriate dilution factor to obtain the analytes correct concentration in the sample.The large dilution factors need to be used cautiously.There is the potential of reading below analytical sensitivity (on high dilutions) and when multiplied by the dilution factor it could cause the prl dose to show an increase.Checking the relative light units (rlus) obtained on neat and diluted results is helpful in troubleshooting.With a true hook effect, the diluted sample (e.G.1:100 or 1:1000) should read much higher than the noise region of the amr.The rlu's for the discordant sample was not made available.Based on the information provided, the potential cause of the discrepant result is unknown, however over dilution of the sample cannot be ruled out.A systemic product performance issue has not been identified.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion codes were revised.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00211 initial report on 30-mar-2021 for a discordant low atellica im prolactin (prl) result compared to higher results when the sample was diluted.Mdr 1219913-2021-00211 supplemental report 1 on 02-jul-2021 for additional information.22-jun-2021: additional information: siemens has been informed of the reagent lot used by the customer.D4: lot number: 185, d4: expiration date: 06/04/2021, h4: device manufacture date: 06/04/2020.

• Brand Name: ATELLICA IM PROLACTIN (PRL)
• Common Device Name: PROLACTIN (PRL) IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11592747
• Report Number: 1219913-2021-00211
• Device Sequence Number: 12984847
• Product Code: CFT
• UDI-Device Identifier: 00630414599748
• UDI-Public: 00630414599748
• Combination Product (Y/N): N
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

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: 06/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995656
• Device Lot Number: 185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 06/22/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/02/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1