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	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received an erroneous result for one patient sample tested with the elecsys prolactin assay on a cobas 8000 e 801 module.It was asked, but it is not known if the erroneous result was reported outside of the laboratory.The customer routinely tests samples for prolactin on their tosoh aia-2000 analyzer.The sample was initially tested on the aia-2000 analyzer, resulting with a prolactin value of 255.8 ng/ml.The physician questioned the result and asked for the sample to be repeated on the e 801 analyzer.The repeat prolactin result from the e 801 analyzer was 343.9 ng/ml.No adverse events were alleged to have occurred with the patient.The serial number of the e 801 analyzer was asked for, but not provided.
Additional Manufacturer Narrative
The patient sample was treated with polyethylene glycol and repeated on the e 801 analyzer, resulting as 133.2 ng/ml (77% recovery).
Additional Manufacturer Narrative
Both analyzers used for prolactin testing provided results above reference ranges.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: 7818081
• Report Number: 1823260-2018-02871
• Device Sequence Number: 19417259
• 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,Followup
• Report Date (Section B): 10/29/2018

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: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/11/2018; 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1