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

Model Number	PROLACTIN G2
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys prolactin gen.2 assay ver.2.1 on a cobas e 411 immunoassay analyzer.The sample initially resulted in a prolactin value of 42.22 ng/ml and this value was reported outside of the laboratory.The sample was sent to another laboratory for testing using a chemiluminescence method and when tested with this method, the prolactin result was 22.50 ng/ml.The sample was treated with polyethylene glycol (peg) and repeated with the chemiluminescence method, resulting in a value of 19.92 ng/ml (89 % recovery).The e411 analyzer serial number is (b)(4).
Additional Manufacturer Narrative
Calibration signals were within expectations.Quality controls were within specified ranges for the dates of sample measurements.The sample coagulation time was shorter than recommended by tube manufacturers.Siemens centaur has a lower macro prolactin detection rate than the elecsys assay.Therefore, it is necessary to perform polyethylene glycol (peg) precipitation for the elecsys prolactin assay which requires this measure for "unexpected high prolactin" samples.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." the investigation could not identify a product problem.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13759830
• Report Number: 1823260-2022-00687
• Device Sequence Number: 5973578
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/26/2022

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: 06/30/2022
• Device Model Number: PROLACTIN G2
• Device Catalogue Number: 03203093190
• Device Lot Number: 52654301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/26/2022
• 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 Age: 27 YR
• Patient Sex: Female