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 Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable (b)(6) results for one patient sample from cobas e601 serial number (b)(4).On (b)(6) 2016, the patient was a prospective blood donor and was tested for (b)(6) antibodies with an abbott architect system and the result was (b)(6).The patient was treated with antibiotics.At that time, a test for treponema pallidum particle agglutination assay (tpha) was performed and the result was (b)(6).On (b)(6) 2016 after finishing the antibiotic treatment, the patient again attempted to donate blood.The patient was tested using the roche method and the result from the primary sample tube was (b)(6).On (b)(6) 2016, an aliquot of the sample was retested for confirmation and the (b)(6) was reproduced at (b)(6).A westernblot analysis (viramed) was performed: immuno-blot for (b)(6): (b)(6).Immuno-blot for (b)(6): (b)(6).The patient's (b)(6) result was always (b)(6).No specific data was provided.The doctor in charge was informed about the results, but no action was taken.The patient was not adversely affected.As a consequence of the unclear (b)(6) status of the patient, no blood from the (b)(6) 2016 donation was used and the patient stayed "blocked" for blood donation.

Manufacturer Narrative

Samples from the patient were submitted for investigation.Based on the results of the investigation with multiple testing methods including western blot, tpla, and rpr2, both samples were found to be repeatedly negative/non-reactive.The negative results generated by the customer were determined to be the correct result for the samples.A general reagent issue could be excluded and no product problem was 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6099020
• MDR Text Key: 59748482
• Report Number: 1823260-2016-01769
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

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: 06923348190
• Device Lot Number: 159493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• 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
• Patient Age: 35 YR