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	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6) (module a).The other analyzer's serial number is (b)(6) (module b).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys prolactin ii results for 1 patient on 2 cobas 8000 e 801 modules.On (b)(6) 2024 the patient's elecsys prolactin ii results were 30.50 ng/ml and 39.9 ng/ml on an e 801 module (analyzer a).On (b)(6) 2024 the initial result was 73.40 ng/ml on analyzer a.The repeated result was 68.0 ng/ml on a second e 801 module (analyzer b).The sample was sent to another laboratory and the result was 39.8 ng/ml.This result was believed to be correct but the result was not reported outside the laboratory.On (b)(6) 2024 the same sample was repeated on analyzer a and the result was 73.7 ng/ml.The sample was repeated as the customer was aware of the patient's clinical history.The questionable results were reported outside the laboratory.The customer does not plan on sending a corrected report.
Additional Manufacturer Narrative
The patient is a fertility patient.The result of 39.8 ng/ml was performed on a siemens analyzer.The calibration and qc were acceptable.There is no indication of a general reagent issue.Peg (precipitation by polyethylene glycol) treatment was performed on the sample with the high prolactin result and the results were acceptable.The results were as expected.The post-peg treatment results were: the sample with the result of 30.5 ng/ml became 20.2 ng/ml.The sample with the result of 73.4 ng/ml became 51.0 ng/ml.Product labeling states: "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 found the event was due to the customer not performing peg treatment on the sample with a high prolactin result.

• 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: 20237044
• Report Number: 1823260-2024-02682
• Device Sequence Number: 15444054
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 07027737190
• Device Lot Number: 76507900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/11/2024
• 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 Age: 35 YR
• Patient Sex: Female