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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter email: (b)(6).The e411 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys prolactin assay (prolactin) on a cobas e 411 immunoassay analyzer.The initial result from the e411 analyzer was 663.0 uiu/ml.The repeat result from the maglumi method was 444 uiu/ml.On (b)(6) 2023 the sample was repeated by the architect method and the result was 21.00 ng/ml (446.80 uiu/ml).The sample was repeated as the result from the e411 analyzer did not correspond to the patient¿s symptoms.
Additional Manufacturer Narrative
The calibration signals from the calibration performed on 24-jul-2023 were within expectations.Quality controls recovered within range for two levels of control.The customer did not run a third level of control on the day of the event.A general reagent problem can be excluded because the provided quality control data is within expectations.The differences between assay results are most likely based on methodological differences.It is recommended to treat the sample with polyethylene glycol (peg) before testing with the elecsys assay and comparing this value with a competitor method.Per product labeling: "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.".

• 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: 17661750
• Report Number: 1823260-2023-02833
• Device Sequence Number: 15230217
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): Y
• Initial Reporter Country: PM
• 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): 09/11/2023

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: 02/29/2024
• Device Catalogue Number: 03203093190
• Device Lot Number: 65549403
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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