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	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys prolactin assay results for 1 patient sample on a cobas 6000 e601 module.The initial result was 0.095 ng/ml.The repeated results were 11.56 ng/ml and 18.54 ng/ml.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.The field service representative found many serum separator tubes where the gel components and the clotted blood have mixed with the serum, which might lead to an incorrect result for the sample.The investigation determined the issue was caused by a pre-analytical handling issue.

• 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: 19655783
• Report Number: 1823260-2024-01918
• Device Sequence Number: 15139863
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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): 08/28/2024

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 Catalogue Number: 03203093190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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