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 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The cobas 8000 core unit serial number was (b)(4).Qc results were within range.

Event Description

The initial reporter complained of (b)(6) results for 1 patient tested for elecsys syphilis (syphilis) on a cobas 8000 core unit.On (b)(6) 2019 the patient was tested on the cobas 8000 core unit and the result was (b)(6).The repeat result from the same instrument was (b)(6).On (b)(6) 2019 a new sample was obtained and the result from the cobas 8000 core unit was (b)(6).The sample from (b)(6) 2019 was repeated on 2 e602 modules and the results were also (b)(6).The sample from (b)(6) 2019 was tested by the antobio method and the result was (b)(6).The result from the tppa method was "(b)(6)" and the rpr result was (b)(6).The patient's boyfriend is a carrier of (b)(6) so a (b)(6) result was expected.

Manufacturer Narrative

Both patient samples were sent to the manufacturer for investigation.The samples were tested and were reactive in all tested treponemal and non-treponemal assays, except the elecsys syphilis assay.During the investigation igm-specific antigens were reactive, but igg-specific antigens were not reactive.Additional testing shows the samples are from a patient with an early syphilis sero-conversion.The sample is considered false non-reactive with the elecsys syphilis assay.False negative results are possible and are documented in 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." no product problem was found.The 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: 8840451
• MDR Text Key: 152687947
• Report Number: 1823260-2019-02767
• 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: 10/24/2019

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: 37025102
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1