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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys prolactin ii on a cobas e 801 analytical unit.The result from the roche assay did not agree with the patient's clinical condition.The sample was tested on the e 801 analyzer, resulting in a prolactin value of 1031 uiu/ml (reference range = 86 - 324 uiu/ml).The patient's magnetic resonance imaging showed relative atrophy of the pituitary gland.The clinician diagnosed the patient with pituitary adenoma and prescribed bromocriptine.The patient did not take the bromocriptine medication.A second sample was collected from the patient in a second hospital and tested on a competitor system later on (b)(6) 2024.This sample resulted in a prolactin value of 7.68 ng/ml (reference range = 2.1 - 17.7 ng/ml) when tested on the competitor system.The doctor at this hospital diagnosed the patient as not having a pituitary tumor.The patient then complained that the customer site misdiagnosed the patient.The complained sample was then sent to a different site for examination with the same competitor system.The prolactin result that was measured on the competitor system was 33.54 ng/ml (reference range = 2.1 - 17.7 ng/ml).The second sample was then sent for testing on the customer's e 801 analyzer and it resulted in a prolactin value of 162 uiu/ml (reference range = 86 - 324 uiu/ml).The roche and competitor results of both samples were consistent.The complained sample was then tested again on the customer's e 801 analyzer on (b)(6)2024, resulting in a prolactin value of 990 uiu/ml.The sample was treated with a polyethylene glycol solution and repeated on the e 801, resulting in a prolactin value of 902 uiu/ml (91 % recovery rate).
Additional Manufacturer Narrative
The investigation could not determine a specific root cause.A general product problem was not found.

• 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: 19096989
• Report Number: 1823260-2024-01138
• Device Sequence Number: 18102953
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 05/08/2024

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian