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

Model Number SYPHILIS

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Calibration and qc were acceptable.Both samples were requested for investigation.

Event Description

The initial reporter complained discrepant results for 1 patient sample tested for elecsys (b)(6) on a cobas 8000 e 602 module.The initial results on the e602 module were 0.068 coi (b)(6) and 0.066 coi (b)(6).The result from the rpr method was 128 (b)(6) and the result from the tppa method was 320 (b)(6).On (b)(6) 2020 the result from a different sample on the e602 module was 0.063 coi (b)(6).The result from the rpr method was 64 (b)(6) and the result from the tppa method was 320 (b)(6).This sample was also tested by the antu method and the result was "(b)(6)." the specific result was not provided.The (b)(6) results from the e602 module were reported outside of the laboratory.On (b)(6) 2020 the original sample was run on the e602 module with a x50 dilution and a x100 dilution and the results were 0.082 coi (b)(6) and 0.084 coi (b)(6) respectively.The e602 module serial number was (b)(4).

Manufacturer Narrative

Two samples were provided for investigation.Rerun of sample #1 and sample #2 with new syphilis reagent had negative results and are consistent with the customer's results.Single antigen analysis determined both samples were negative without any special increased signal.There are no signs of infection in these two samples from any single antigen.No product problem could be found.

• Brand Name: ELECSYS SYPHILIS
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10051651
• MDR Text Key: 222559904
• Report Number: 1823260-2020-01219
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 41371400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR