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

Model Number PROLACTIN G2

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant low results for two samples from the same patient tested with the elecsys prolactin assay on a cobas e 411 immunoassay analyzer.The second sample also had a discrepant low prolactin result when tested on a second e 411 analyzer at a different site.No incorrect results were reported outside of the laboratory.The first sample resulted with a prolactin value of 685 miu/l when tested on the customer's e 411 analyzer.The sample was repeated on an abbott analyzer, resulting with a prolactin value of 1432.00 miu/l.The second sample resulted with a prolactin value of 591.90 miu/l when tested on the customer's e 411 analyzer on (b)(6) 2020.The sample was repeated on a second e 411 analyzer at another site, resulting with a prolactin value of 568.0 miu/l.The sample was repeated on an abbott analyzer, resulting with a prolactin value of 1301.2 miu/l.Values from both samples were repeatable for each respective system (abbott and roche).The serial number of the customer's e 411 analyzer is (b)(4).

Manufacturer Narrative

The roche prolactin assay detects more macro prolactin compared to centaur.The patient samples were found to contain a significant amount of macro prolactin and possibly other macro-molecular interferents (e.G.Heterophilic antibodies).The abbott prolactin result appears significantly impacted by macro prolactin and/or some kind of other interference (e.G.Heterophilic antibodies).

Manufacturer Narrative

Two samples were returned for investigation.Based on the available data and measured results, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch fields d10 and h3 have been updated.

• 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: 9675911
• MDR Text Key: 213230589
• Report Number: 1823260-2020-00323
• 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,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROLACTIN G2
• Device Catalogue Number: 03203093190
• Device Lot Number: 426972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR