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

Model Number SYPHILIS

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Address continued: (b)(6).The sample was requested for investigation.(b)(4).

Event Description

The initial reporter complained of false negative results for 1 patient tested for elecsys (b)(6) on a cobas 6000 e 601 module.No quantitative results were provided for any of the tests.The e601 module serial number was (b)(4).

Manufacturer Narrative

Sample material was requested for investigation, but was not able to be provided.The cause of the event could not be determined.

Manufacturer Narrative

Section d4 lot number and expiration date were updated.The customer provided data showing the syphillis results for the patient and the patient's baby were the same when tested on the e601 module on (b)(6) 2019: the patient had a result of 0.402 coi (negative) the patient's baby had a result of 0.569 coi (negative) the patient delivered the baby on (b)(6)2019.

• 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: 9519703
• MDR Text Key: 219778706
• Report Number: 1823260-2019-04520
• 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,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: 41371402
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1