MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROLACTIN ASSAY; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number	03203093190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two samples from the same patient tested with the elecsys prolactin assay on a cobas e411 disk.The first sample initially resulted in a prolactin value of 49.88 ng/ml.The sample was repeated at another laboratory using an unknown method on (b)(6) 2025, resulting in a prolactin value of 27.3 ng/ml.The sample was repeated on an i-flash instrument on (b)(6) 2025, resulting in a prolactin value of 56.05 ng/ml.The sample was repeated on (b)(6) 2025, resulting in a prolactin value of 32.65 ng/ml.No questionable results were reported outside of the laboratory for this sample.The second sample resulted in a prolactin value of 11.23 ng/ml on (b)(6) 2025.The sample was repeated on an i-flash instrument, resulting in a prolactin value of 14.76 ng/ml.
Additional Manufacturer Narrative
The customer stated that they performed an additional measurement of the sample on (b)(6) 2025.This measurement was performed with the l-flash method, resulting in a prolactin value of 27 ng/ml.Calibration and controls run prior to the event were acceptable.A general reagent issue can be excluded.Provided calibration data showed three failed calibrations and there was a high amount of quality control results outside of range.A review of the provided alarm trace showed no relevant alarms and the day of the event was not covered.There was evidence of the mixer causing foaming of reagent packs with lower volume.Precision studies were acceptable.The customer was using eppendorf tubes and these are not recommended for use with the system.The investigation determined the issue is consistent with insufficient pre-analytic sample handling as eppendorf tubes are not recommended for use on the system.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22059782
• Report Number: 1823260-2025-01564
• Device Sequence Number: 15530926
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K964748
• 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): 06/18/2025

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: 02/28/2025
• Device Catalogue Number: 03203093190
• Device Lot Number: 821070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female