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

Catalog Number 07251378190

Device Problem False Negative Result (1225)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

There was an allegation of a false negative elecsys syphilis result for one patient from the cobas 8000 core unit.The patient was tested with colloidal gold method and the result was 13.468 coi (positive).A few days later, the patient was tested using the antu platform and the result was 11.751 coi (positive).Using the same sample as the antu test, the patient was tested using the roche method and the result was 0.0921 coi (negative).

Manufacturer Narrative

The cobas 8000 core unit serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d4 catalog no, d4 lot no, and primary udi number were updated.As no sample material from the patient was available for further testing, a specific root cause could not be determined.A general product problem was not 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
• 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: 19135575
• MDR Text Key: 340514432
• Report Number: 1823260-2024-01201
• 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: 04/30/2024

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 Catalogue Number: 07251378190
• Device Lot Number: 735603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• 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
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Race: Asian