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 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Calibration signals were acceptable, however, the last calibration was performed on (b)(6) 2020.Qc results were acceptable.The investigation is ongoing.

Event Description

The initial reporter complained of questionable (b)(6) results for 1 patient sample tested for elecsys (b)(6) on a cobas 6000 e 601 module.The patient had unsafe sexual intercourse."the foreskin of the patient¿s glans flaky erosion for a week and there are some macula on the patient¿s back.Patient will have a pain at sometimes." the patient went to the doctor based on these symptoms and the following results were obtained: the initial result from the e601 module was (b)(6).The sample was repeated on the same e601 module with a result of (b)(6).The sample was repeated on a different e601 module at a different site with results of (b)(6).The sample was tested by the trust method and the result was "(b)(6)." no specific result was provided.The sample was tested by the abbott method with a result of (b)(6).The roche results were reported outside of the laboratory.The e601 module serial number was (b)(4).The serial number for the other e601 module was not provided.

Manufacturer Narrative

The patient sample was not available for investigation.During a review of the alarm trace data, no relevant alarms were observed.The reagent performs within specification as calibration and qc were within the specified ranges.Product labeling states: "a negative test result does not completely rule out the possibility of an infection with treponema pallidum.Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of a syphilis infection can occasionally yield negative findings." the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 10771627
• MDR Text Key: 214395592
• Report Number: 1823260-2020-02734
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 443797
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT TAKES NO MEDICATION
• Patient Age: 34 YR