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 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received (b)(6) syphilis elecsys results for four patient samples when compared to the abbott anti-tg assay.Patient a abbott result was (b)(6) and the syphilis elecsys results were (b)(6).Patient b abbott result was (b)(6) and the syphilis elecsys results were (b)(6).Patient c abbott result was 1.22 and the syphilis elecsys results were (b)(6).Patient d abbott result was (b)(6) and the syphilis elecsys results were (b)(6).The samples were submitted for preliminary investigation and were tested using immunoblot and the results were: patient a: negative.Patient b: "cannot discriminate".Patient c: "cannot discriminate".Patient d: "cannot discriminate".Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown.There was no allegation of an adverse event.Information concerning the roche analyzer used by the customer was requested but was not provided.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6907101
• MDR Text Key: 89575129
• Report Number: 1823260-2017-02166
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1