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

Catalog Number	07027737190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The qc was within the assigned ranges.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results not matching the patient's clinical picture for 1 patient sample when tested with elecsys prolactin g2 (prl2) assay on a cobas e801 analytical unit.Initial result: 344 uiu/ml.The customer questioned the initial result and repeated the sample.1st repeat result: 2940 uiu/ml (using a dilution factor of 1:10).2nd repeat result: 2900 uiu/ml (using a dilution factor of 1:100).3rd repeat result: 2900 uiu/ml (using a dilution factor of 1:200).A new sample was drawn and tested on (b)(6) 2025, resulting in a prl2 value of 336 uiu/ml.The customer alleged that the lower results did not match the patient's clinical picture.
Additional Manufacturer Narrative
The sample was not available for investigation.A general reagent issue can be excluded because quality validation data were within expectations.The product labeling states: "there is no high-dose hook effect at prolactin concentrations up to 270000 iu/ml (12690 ng/ml)." the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PROLACTIN II
• 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: 22010661
• Report Number: 1823260-2025-01466
• Device Sequence Number: 15449817
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/20/2025

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: 05/31/2025
• Device Catalogue Number: 07027737190
• Device Lot Number: 76507901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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