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	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys prolactin ii assay (prol) results from an unspecified number of patient samples tested on the cobas e411 rack.The initial results were reported outside of the laboratory.The reporter noticed the discrepant results upon performing a comparison between the analyzer and a siemens analyzer.The reporter used patient samples processed from (b)(6) 2023 to (b)(6) 2023.The reporter did not perform the recommended patient sample pretreatment using the polyethylene glycol (peg) precipitation test.The reporter was advised to perform this procedure.Please refer to the attachment (b)(6 in the medwatch for the table containing the highlighted examples of questionable patient results.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The patient samples were not available for investigation.The investigation reviewed the calibrations; the results were within specifications.The investigation reviewed the qc recovery data; the qc recovery data were within specifications.The investigation reviewed the instrument check on 21-nov-2023; the analyzer was performing within specifications.The differences between the results are most likely based on methodological differences.Due to the various standardization methods available and different assay setups and compositions (like the usage of different antibodies), it is possible to receive different results when using another manufacturer's test.The results show the same clinical picture of results above expectations.A general reagent issue can most likely be excluded because the qc recovery data were within specifications.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18170169
• Report Number: 1823260-2023-03678
• Device Sequence Number: 7652657
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): Y
• 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): 12/27/2023

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: 09/30/2024
• Device Catalogue Number: 07027737190
• Device Lot Number: 71614201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/27/2023
• 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