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

Catalog Number 06923348190

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for (b)(6) on a cobas 8000 e 801 module (e801).The erroneous result was not reported outside of the laboratory.The sample was tested on the e801 analyzer, resulting as 0.1 coi ((b)(6)).The sample was also tested using the mediease tpla method on a cobas 6000 c (501) module, resulting as 49.0 t.U.((b)(6)).The sample also resulted with values of 40.0 t.U.And 29.0 t.U.When tested with the mediease tpsa method.The sample had an rpr value of 0.3.No units of measure were provided for the rpr value.No adverse events were alleged to have occurred with the patient.The serial number of the e801 analyzer was asked for, but not provided.

Manufacturer Narrative

The mediase tpla test has been clarified as the mediace tpla assay.The affected sample was tested at another site (sekisui) using different test methods, including mediace tpla, espline tp by fujirebio, "other company rpr reagent", and recomline treponema igg/igm western blots.Refer to the attachment for all additional sample results.Data was provided for a second patient sample, but this sample had no issues.The negative syph result measured by the customer was confirmed negative by the recomline treponema igg/igm western blots.The non-treponemal testing (rpr) result was negative as well.In contrast, tpla testing is positive.The investigation was unable to find a definitive root cause.No further sample volume was available for additional investigation.(b)(6).

• 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: 7302336
• MDR Text Key: 101578838
• Report Number: 1823260-2018-00610
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06923348190
• Device Lot Number: 247710
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1