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 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys prolactin gen.2 assay ver.2.1 on a cobas e 411 immunoassay analyzer.The sample initially resulted in a prolactin value of 42.22 ng/ml and this value was reported outside of the laboratory.The sample was sent to another laboratory for testing using a chemiluminescence method and when tested with this method, the prolactin result was 22.50 ng/ml.The sample was treated with polyethylene glycol (peg) and repeated with the chemiluminescence method, resulting in a value of 19.92 ng/ml (89 % recovery).The e411 analyzer serial number is (b)(4).

Manufacturer Narrative

Calibration signals were within expectations.Quality controls were within specified ranges for the dates of sample measurements.The sample coagulation time was shorter than recommended by tube manufacturers.Siemens centaur has a lower macro prolactin detection rate than the elecsys assay.Therefore, it is necessary to perform polyethylene glycol (peg) precipitation for the elecsys prolactin assay which requires this measure for "unexpected high prolactin" samples.Per product labeling: "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 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13759830
• MDR Text Key: 293165458
• Report Number: 1823260-2022-00687
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PROLACTIN G2
• Device Catalogue Number: 03203093190
• Device Lot Number: 52654301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female