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

Catalog Number	03203093190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer states that the roche platform has consistently higher results for patient samples tested with the elecsys prolactin assay when compared to prolactin results generated from competitor systems.The customer provided data for one patient sample with an erroneous prolactin result.When tested twice on a cobas 8000 e 602 module, the sample resulted with prolactin values of 39.73 ng/ml and 40.18 ng/ml.An erroneous value from the sample was reported outside of the laboratory and questioned by the physician.The sample was then sent to another laboratory for testing on a beckman system.When repeated on the beckman system, the sample resulted with a prolactin value of 29.8 ng/ml.No adverse events were alleged to have occurred with the patient.The serial number of the e 602 analyzer is (b)(4).Based on a review of worldwide data of qc recovery for the reagent/calibrator lot combination used by the customer, no reagent issue was found.In cases of implausible high prolactin values, product labeling recommends sample precipitation by polyethylene glycol (peg) in order to estimate the amount of biological active monomeric prolactin.The customer does not use this pre-treatment procedure for sample testing.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7855232
• Report Number: 1823260-2018-03025
• Device Sequence Number: 13938194
• Product Code: CFT
• UDI-Device Identifier: 04015630921546
• UDI-Public: 04015630921546
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 04/30/2019
• Device Catalogue Number: 03203093190
• Device Lot Number: 29313001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1