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

Catalog Number	03203093190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
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 one patient sample tested with the elecsys prolactin assay on a cobas e411 rack.The sample initially resulted in a prolactin value of 0.866 ng/ml.The sample was repeated three times, resulting in values of 6.05 ng/ml, 3.50 ng/ml, and 2.18 ng/ml.
Additional Manufacturer Narrative
The patient sample was sent to a reference laboratory where it was tested using an unknown method, resulting in a prolactin value of 6.20 ng/ml.This value was deemed correct by the customer.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20749497
• Report Number: 1823260-2024-03388
• Device Sequence Number: 8756046
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/20/2024

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: 06/30/2025
• Device Catalogue Number: 03203093190
• Device Lot Number: 76506301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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