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

Catalog Number	07027737190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).(b)(4).
Event or Problem Description
The customer complained of questionable elecsys prolactin assay results from 2 separate samples from 1 patient that were not matching the patient's clinical picture.Please refer to the attachment to this medwatch for patient data.The erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was not provided.The prolactin reagent lot used at the investigation site was 293123 with an expiration date of 31-may-2019.The cobas e801 used at the investigation site was serial number (b)(4).The investigation is currently ongoing.
Additional Manufacturer Narrative
The calibration data is within expectations and the qc recovery is within specified ranges.Therefore, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 7826025
• Report Number: 1823260-2018-02909
• Device Sequence Number: 13774839
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 4015630940097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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 Catalogue Number: 07027737190
• Device Lot Number: 29312300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR