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

Model Number	SYPHILIS E2G
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.There was no sample left to return for investigation.The customer did not provide any calibration and qc information but confirmed the data was within expected/ specified ranges.According to the data provided a very early syphilis infection / (pre-) seroconversion phase was determined to be the root cause.Seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization.The pre-seroconversion window describes the amount of time when a patient is already infected, however, antibodies are not detectable yet.The blood donor had an elevated, not yet positive coi result during the first donation on (b)(6) 2021 and a clear positive result on (b)(6) 2021 (both confirmed by abbott architect).The data suggests that the first sample from the blood donor was drawn during the phase of very early syphilis infection within a window period of seroconversion, while seropositivity was not yet completely achieved.Product labeling states, "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 elecsys syphilis reagent performs within specification.
Event or Problem Description
The initial reporter received a questionable elecsys syphilis result for one patient sample with the cobas e 801 module serial number unknown.On (b)(6) 2021, the initial result from a blood donation was 0.978 coi (non-reactive).This result was reported outside of the laboratory.On (b)(6) 2021, the patient made another blood donation with a result of 34.2 coi (reactive).The sample was repeated with an abbott architect with a result of 15.04 s/co (reactive).After the reactive results from (b)(6) 2021, the sample from (b)(6) 2021 was tested further.The abbott architect result was 0.18 s/co (non-reactive).The tppa 1:640 was positive, fta abs igg >1:10 was positive, and fta abs igm 1:80 was positive.

• Brand Name: SYPHILIS ELECSYS E2G 300
• Common Device Name: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12338826
• Report Number: 1823260-2021-02410
• Device Sequence Number: 14159495
• Product Code: LIP
• UDI-Device Identifier: 04015630940356
• UDI-Public: 04015630940356
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160910
• 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
• Report Date (Section B): 08/18/2021

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 Expiration Date: 03/31/2022
• Device Model Number: SYPHILIS E2G
• Device Catalogue Number: 07251378190
• Device Lot Number: 53442101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR