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 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the quality control and external proficiency data did not indicate any issues.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable (b)(6) elecsys syphilis results for one patient from cobas 8000 cobas e 602 module serial number (b)(4).The patient information was provided as "multiparous female ((b)(6)) with a history of substance abuse and complicated social history".The patient presented at another facility at (b)(6) gestation with early labor and premature rupture of membranes.The patient had blood work, received betamethasone as well as iv penicillin, and was then transferred to this facility for high risk pregnancy care.On (b)(6) 2019, the syphilis eia result from this other facility was (b)(6) (biorad bioplex).The results from the blood work at the first facility were not provided to this facility.Therefore, the patient had new blood work performed including pre-natal screening blood tests.On (b)(6) 2019, the elecsys syphilis eia result from the cobas e602 was (b)(6).A urine toxicology screen was positive for cocaine and the patient had a history of recent cocaine use.The patient noted taking ibuprofen and smoking cigarettes but no other medications or supplement history.The patient received betamethasone as well as iv ampicillin and erythromycin as per protocol for premature rupture of membranes.The patient¿s contractions ceased and she remained at this facility from (b)(6) 2019 whereupon she was transferred back to the first facility at her request.On (b)(6) 2019, the syphilis eia result from the other facility was (b)(6) (biorad bioplex).On (b)(6) 2019, a frozen aliquot of the (b)(6) 2019 sample was retested and the result from the cobas e602 was (b)(6).At the other facility, the repeat result for this same sample was (b)(6) (biorad bioplex).There was no allegation of an adverse event.

Manufacturer Narrative

Sample from the patient was submitted for investigation.The elecsys syphilis result was repeatedly non-reactive using different lots of reagent.The rpr2 result was 0.000 r.U (negative) and tpla2 was 19.6 t.U (reactive).The sample was negative for igm and igg anti-treponemal antibodies.The customer¿s negative elecsys syphilis result could be reproduced and no product problem could be found.The sample is most likely truly negative for elecsys syphilis.

• 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: 8784265
• MDR Text Key: 150876140
• Report Number: 1823260-2019-02561
• 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: 10/07/2019

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 Model Number: SYPHILIS
• Device Catalogue Number: 06923348190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR