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

Catalog Number	07027737190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pure e 402 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys prolactin ii assay (prol) result from one patient sample tested on the cobas pure e 402 analytical unit.On (b)(6) 2024, the result of the initial sample from the analyzer was 736.00 miu/l with a data flag.The physician did not agree with the result and requested a rerun in another laboratory.The repeat result from the other laboratory was reportedly normal.On (b)(6) 2024, the result of a new sample was 210.00 miu/l.This result was considered normal and was within the laboratory's reference range.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on 20-feb-2024.There was no influence of calibration on the event.The investigation reviewed the qc data.The qc levels were within specifications before the event and the system was used for patient sample measurement.The investigation reviewed the alarm trace and a "sample short" alarm was noted on (b)(6) 2024.The investigation reviewed the customer's handling of patient samples.The patient sample was inverted 3-5 times and had a clotting time of 15 to 30 minutes.The investigation determined that the number of inversions and the clotting time were insufficient as the recommended number of inversions is 8 to 10 times and the recommended clotting time is usually more than 30 minutes.A general reagent problem was not present, because the qc before the event was within specifications.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 19297627
• Report Number: 1823260-2024-01421
• Device Sequence Number: 20337486
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• 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): 07/17/2024

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: 05/30/2025
• Device Catalogue Number: 07027737190
• Device Lot Number: 765079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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: Male