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

Catalog Number	07251378190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable negative results for 1 patient's sample tested with elecsys syphilis assay on two cobas 8000 cobas e801 immunoassay analyzers when compared to cobas c501 and c502 rapid plasma reagin (rpr).The customer's laboratory: cobas 8000: cobas c501 rpr: 1st run: positive (2.88 accompanied with a data flag).2nd run: positive (38.77 accompanied with a data flag, and tested with a decrease dilution).Cobas c502 rpr: 1st run: positive.2nd run: positive.Two cobas e801: 1st run: 0.213: negative (line a e801).2nd run: 0.114: negative (line c e801).3rd run: 0.0956: negative (line a e801).Manual rpr: negative (1:128 fold).Serodia treponema-pallidum particle agglutination (tppa): positive.The field service engineer (fse) brought the sample to another laboratory for further cross-checking.Cobas e801: 1st run: neat sample: 0.0963: negative.2nd run: 0.106: negative (1:10 manual dilution).Manual rpr: 1st run: positive (tested with 1:1 dilution).2nd run: weak positive (tested with 1:2 dilution).3rd run: negative (tested with 1:4 dilution).4th run: negative (tested with 1:8 dilution).5th run: negative (tested with 1:16 dilution).6th run: negative (tested with 1:32 dilution).7th run: negative (tested with 1:64 dilution).8th run: negative (tested with 1:128 dilution).A different laboratory: cobas 6000: cobas c501 rpr: 1st run: positive (2.4 accompanied with a data flag).2nd run: positive (39.27 accompanied with a data flag, and tested with a decrease dilution).3rd run: positive (100.51, tested with 1:20 fold).
Additional Manufacturer Narrative
The serial number for one e801 module was 18e3-09.The serial number for the other e801 module was not provided.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The sample was received for investigation on 10-nov-2023.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and qc results were within ranges.The negative results of the samples in the elecsys syphilis assay, as reported by the customer, were confirmed.There was no evidence for single treponemal antigen reactivity (confirmed by inno-lia syphils score).No high-dose hook effect was observed in the elecsys syphilis assay.The investigation did not identify a product problem.The elecsys syphilis assay performs within specifications.The cause was consistent with a sample-specific discrepancy.Product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other finding.".

• Brand Name: ELECSYS SYPHILIS
• Common Device Name: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18031714
• Report Number: 1823260-2023-03469
• Device Sequence Number: 17630879
• Product Code: LIP
• UDI-Device Identifier: 04015630940356
• UDI-Public: 04015630940356
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• PMA/510(K) Number: K160910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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: 12/31/2023
• Device Catalogue Number: 07251378190
• Device Lot Number: 682565
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 01/02/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/05/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: Asian