MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SYPHILIS; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Model Number SYPHILIS

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with elecsys syphilis on a cobas 6000 e 601 module.The sample was aliquoted into two tubes.One tube of sample was diluted 1/10 and tested with an unknown fta-abs igm antibody test, resulting with a (b)(6) value on (b)(6) 2019.The second tube of sample was tested on the e 601 analyzer on (b)(6) 2019, resulting with a value of (b)(6), which was reported outside of the laboratory.On (b)(6) 2019, the patient's syphilis result was (b)(6).The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

Calibration signals were within expected ranges.Quality controls tested on (b)(6) 2019 and (b)(6) 2019 were within range.Of the provided quality control data, all results were within specified ranges.Upon review of the alarm trace, no relevant alarms were observed on (b)(6) 2019.Two samples from the patient were provided for investigation.The results obtained by the customer could be duplicated.The sample was non reactive for the elecsys syphilis assay and was reaction for tpla and rpr.The sample showed reactivity against specific igm antibodies and no reactivity against specific igg antibodies.Taking all results into account, the sample was derived from an early syphilis seroconversion.The elecsys syphilis results are still non-reactive (approximately at 0.8 coi), however all results are close to the cut-off value of 1.0 coi.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.Per product labeling: "a negative test result does not completely rule out the possibility of an infection with syphilis.Serum or plasma samples from the very early (preseroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings." the elecsys syphilis assay performs within specification.

• Brand Name: ELECSYS SYPHILIS
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9401988
• MDR Text Key: 219135793
• Report Number: 1823260-2019-04184
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K160910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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: 11/30/2019
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 37025101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR