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

Model Number	SYPHILIS
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's calibration and qc results were ok.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys syphilis results for one patient tested on two cobas 8000 e 602 modules.The patient had two samples collected for testing.On 16-jun-2021, the customer performed syphilis antibody testing on an abbott alinity analyzer and a manual rpr syphilis antigen test with the patient's first sample.For confirmation, the customer had a second sample collected on (b)(6) 2021.Both samples were tested on the e 602 modules as well as the abbott alinity analyzer.The customer provided a serial number for one e 602 module, (b)(4) , the other e 602 module serial number was requested but not provided.The customer did not specify e 602 module the provided serial number belonged to.The patient's abbott syphilis reactive results were reported outside the laboratory.The patient's elecsys syphilis non-reactive results were not reported outside the laboratory.
Additional Manufacturer Narrative
The customer confirmed a positive syphilis result was expected for the patient.The investigation reviewed the customer's calibration and qc data and the results were ok.The customer provided the patent's sample collected on (b)(6)-2021 for an investigation.The investigation tested the patient's sample on a cobas 8000 e 602 module and a cobas 8000 c 502 module.The patient's sample was non-reactive for elecsys syphilis, rpr, tpla, single antigen analysis igg and igm.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 12253270
• Report Number: 1823260-2021-02233
• Device Sequence Number: 14664488
• Product Code: LIP
• UDI-Device Identifier: 04015630934881
• UDI-Public: 04015630934881
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 09/14/2021

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: 12/31/2021
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 516770
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR