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

Catalog Number 07251378190

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of a questionable syphilis elecsys e2g result from the cobas e 801 analytical unit.The result from the cobas e801 was 0.0892 (negative).The result by trust method (shanghai rongsheng) was weak positive 1:1.At another site, the rpr result was weak positive 1:1.

Manufacturer Narrative

The investigation determined the issue was consistent with a sample-specific discrepancy.The elecsys syphilis assay performed within specification.

• 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: 18335098
• MDR Text Key: 331050993
• Report Number: 1823260-2023-04027
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 04015630940356
• UDI-Public: 04015630940356
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 12/22/2023

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: 12/31/2023
• Device Catalogue Number: 07251378190
• Device Lot Number: 682565
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1