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

Model Number PROLACTIN G2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

On e411 analyzer serial number (b)(4), there were many alarms indicating issues with liquid level detection.Due to this, a liquid level detection circuit board was replaced.This event occurred in (b)(6).Udi number = (b)(4).Phone number was provided as (b)(6).

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys prolactin gen.2 assay on two cobas e 411 immunoassay analyzers.The results obtained on the e411 analyzers did not agree with results obtained using an unknown chemiluminescence immunoassay (clia) method.No incorrect results were reported outside of the laboratory.The first sample was tested on e411 analyzer serial number (b)(4), resulting in a prolactin value of 66.52 ng/ml.When tested using the clia method, the result was 44.4 ng/ml.The second sample was tested on e411 analyzer serial number (b)(4), resulting in a prolactin value of 20.03 ng/ml.When tested using the clia method, the result was 12.7 ng/ml.The third sample was tested on e411 analyzer serial number (b)(4), resulting in a prolactin value of 38.33 ng/ml.When tested using the clia method, the result was 28.0 ng/ml.All three samples were tested on another e411 analyzer (serial number unknown) and the results were reproducible when compared to results from e411 analyzer serial number (b)(4).No specific values were provided.

Manufacturer Narrative

The first patient sample resulted in the following additional test data: b12 = 582.9, cort = 13.44, ferr = 97.14, ft3 = 3.80, ft4 = 1.17, insulin = 7.19, pth = 53.19, tsh = 2.03, vitd = 22.54.No units of measure were provided for these tests.This patient was born on (b)(6) 1982.Medwatch field a2.Has been updated.The second patient sample resulted in the following additional test data: fsh = 54.41, ft4 = 1.03, lh = 26.04, prog = < 0.050, tsh = 2.83, vitd = 48.56.No units of measure were provided for these tests.This patient was born on (b)(6) 1976.The third patient sample resulted in the following additional test data: fsh = 4.03, ft4 = 1.21, toxigg = 0.247, toxigm = 0.204, tsh = 1.44, vitd = 34.41.No units of measure were provided for these tests.This patient was born on (b)(6) 2000.The provided calibration data showed that signals were within expected ranges, but at the lower end.The provided quality control data was within range.Quality control data from (b)(6) 2021 was not provided.Other assays measured for the patient samples showed reagent short alarms.A roche field representative noticed this and decided to check the probe.A liquid level detection circuit board was replaced.Performance testing was run.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 customer did not perform peg treatment of the affected samples.The investigation could not identify a product problem.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11999857
• MDR Text Key: 256227976
• Report Number: 1823260-2021-01738
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: PROLACTIN G2
• Device Catalogue Number: 03203093190
• Device Lot Number: 482682
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR