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

Catalog Number	09015051190
Medical Device Problem Codes	False Negative Result (1225); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys syphilis results for 1 patient on a cobas e 801 analytical unit.On (b)(6) 2024 the patient produced a non-reactive result.On (b)(6) 2024 a new sample was drawn and the results were repeatedly reactive with an alarm and a flag.The results were 1.01 coi, 1.00 coi, and 1.02 coi.A reactive result was reported to the physician.The sample was automatically repeated and the result was nonreactive (0.971 coi).The sample was manually programmed to repeat and the result was nonreactive (0.979 coi).The sample was repeated and the results were "repeatedly reactive" (1.00 coi, 0.997 coi, and 1.02 coi).This sample from (b)(6) 2024 was sent to another laboratory for confirmation testing, but the results of the confirmation test have not been received at this time.It is unknown which result is correct.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative verified the instrument functionality by performing successful instrument checks and a precision test.All verification tests passed.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc were within acceptable ranges.The investigation did not identify a product problem.

• 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: 19230097
• Report Number: 1823260-2024-01333
• Device Sequence Number: 14916756
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 07/31/2024
• Device Catalogue Number: 09015051190
• Device Lot Number: 73561001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 34 YR
• Patient Sex: Male