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

Catalog Number 09015051190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e 801 analytical unit serial number was (b)(6).Calibration was last performed on 10-jul-2023.Qc was acceptable.The sample was received for investigation.The sample was negative for both treponemal tests: elecsys syphilis: 0.056 coi (negative).Sekisui method: 0.0 t.U.The sample was negative with a non-treponemal test: sekisui method: 0.00 r.U.The investigation is ongoing.

Event Description

We received an allegation of a discrepant negative result for 1 patient sample tested for elecsys syphilis (syphilis) on a cobas e 801 analytical unit.The elecsys syphilis result was 0.0799 coi (negative).The inno-lia syphilis result was positive.

Manufacturer Narrative

The sample underwent further investigation.The result of the elecsys syphilis test was 0.090 coi (negative).The sample was diluted at 1:10 and 1:20 and tested with the elecsys syphilis and 2 other methods.All results were negative.Based on the investigation results, the sample is considered to be correctly negative with the elecsys syphilis assay.The assay performs within specification.The investigation did not identify a product problem.

• 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
• 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: 17998127
• MDR Text Key: 326420807
• Report Number: 1823260-2023-03417
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 07613336171998
• UDI-Public: 07613336171998
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K160910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 09015051190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1