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

Catalog Number	07027737190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A general reagent or analyzer issue can be excluded, as qc was acceptable.No information about a possible polyethylene glycol (peg) treatment of the sample was provided, and therefore, this mandatory action for "unexpected high sample results" was missing.The product labeling states: "in case of implausible high prolactin values, a precipitation by polyethylene glycol (peg) is recommended in order to estimate the amount of the biological active monomeric prolactin.See section "sample pretreatment by polyethylene glycol (peg) precipitation" for further details." the investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue (missing peg treatment/missing macro prolactin assessment) at the customer site.Preanalytics are within the customer's responsibility.
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number was (b)(6).The qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys prolactin ii assay on a cobas pure e 402 analytical unit.Initial result: 60.4 ng/ml.The customers sent the sample to another laboratory using siemens, and the 1st repeat result was 40.5 ng/ml.The customer then repeated the sample 3 times, and the repeat results were 60.1 ng/ml, 60 ng/ml, and 60.8 ng/ml.No questionable results were reported outside the laboratory.

• 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: 24207525
• Report Number: 1823260-2026-00309
• Device Sequence Number: 5509537
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 03/02/2026

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: 07027737190
• Device Lot Number: 899360
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/02/2026
• 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