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

Catalog Number	03203093190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys prolactin assay results from an unspecified number of patient samples tested on the cobas e 411 analyzer (rack system).The reporter stated that the initial and repeat results from the analyzer were high, while the results from a competitor analyzer were within the normal range.The reporter acknowledged the difference in the analyzer's reference ranges but stated that it was not possible based on the population.The reporter stated that they have a process to repeat patient samples with high results, and if the results from the repeat are also high, magnetic resonance imaging (mri) or macroprolactin is ordered; one physician would also send out the samples of his patients with high results to another laboratory.
Additional Manufacturer Narrative
Medwatch field b3 date of event updated.The investigation included a review of the calibration, qc data, and alarm trace: the calibration results show a slight increase in calibration signal 2 with the agent lot change; the calibration signals were within the expected ranges.The qc results were within the 2 standard deviation range surrounding the date of event.There was no indication of a performance issue with the reagent.The alarm trace did not indicate any issues.The investigation noted that the results from the analyzers were from different patient samples.Regarding the differences in the results generated with the different analyzers, it needs to be taken into account that the assays from different vendors can generate different values.This relates to the overall set-ups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.The investigation did not identify a product problem.

• 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: 22750570
• Report Number: 1823260-2025-02421
• Device Sequence Number: 9558061
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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 Sex: Unknown