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	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e411 disk serial number was (b)(6).Qc was within range.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patients' serum/plasma samples tested with elecsys prolactin g2 (prolactin ii) assay on a cobas e411 immunoassay analyzer when compared to a different analyzer at a different facility.Sample (b)(6) (patient (b)(6)) was tested on (b)(6) 2024: initial result: 31.7 ng/ml.Repeat result: 18.66 ng/ml (tested on another analyzer in a different laboratory).Sample (b)(6) (patient (b)(6)) was tested on (b)(6) 2024: initial result: 28.5 ng/ml.Repeat result: 13.88 ng/ml (tested on another analyzer in a different laboratory).Sample (b)(6) (patient (b)(6) ) was tested on (b)(6) 2024: initial result: 42.36 ng/ml.Repeat result: 19.78 ng/ml (tested on another analyzer in a different laboratory).No questionable results were reported outside the laboratory.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The pre-analytic data was provided and showed that the clotting time was below the manufacturer's specification.Qc was performed and it was within range.No further issues were reported afterward.The investigation did not identify a product problem.The cause was due to a handling issue with the patient sample.

• 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: 19453846
• Report Number: 1823260-2024-01653
• Device Sequence Number: 18279037
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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): 07/03/2024

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: 10/31/2024
• Device Catalogue Number: 03203093190
• Device Lot Number: 71613700
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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