MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SYPHILIS ELECSYS E2G 300; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Model Number SYPHILIS E2G

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the calibration and qc were acceptable.The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for 1 patient tested for syphilis elecsys on a cobas 8000 e 801 module serial number (b)(4) compared the pcr method.The initial syphilis result was (b)(6) and the pcr treponema pallidum result was (b)(6).A new sample was collected.On (b)(6) 2019 the syphilis result for the new sample was (b)(6) and the pcr treponema pallidum result was (b)(6).The (b)(6) syphilis result was reported outside of the laboratory.The physician questioned the result.There was no allegation of an adverse event.

Manufacturer Narrative

The customer provided two samples for investigation.The samples were non-reactive for elecsys syphilis assay and all non-treponemal assays but reactive when tested using the competitor¿s treponemal assays.In this investigation the specific igm antigens showed reactivity with the first sample, while the igg- specific antigens remain non-reactive.The second draw shows an increase in igm reactivity and a slight increase in one igg specific-antigen.These findings indicate the possibility of an early phase of syphilis infection.The package insert addresses the possibility of a false non-reactive results: "a negative test result does not completely rule out the possibility of an infection with treponema pallidum.Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings." the reagent performs within specification.

• Brand Name: SYPHILIS ELECSYS E2G 300
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8784449
• MDR Text Key: 150874647
• Report Number: 1823260-2019-02567
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYPHILIS E2G
• Device Catalogue Number: 07251378190
• Device Lot Number: 370224
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENICILLIN; PENICILLIN
• Patient Age: 68 YR