MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG CONFIRMATORY TEST; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned (b)(6) results for 1 patient tested for elecsys (b)(6) and elecsys (b)(6) confirmatory test ((b)(6) confirmatory test) on an unspecified roche instrument.Based on the data provided, the results from the (b)(6) confirmatory test are a reportable malfunction.Refer to attached data for the patient results.The (b)(6) roche results were reported outside of the laboratory where they were questioned by the physician since the hbv dna tests for the patient were (b)(6).The customer suspects an interference affecting the roche results.The type of roche instrument and serial number were not provided.

Manufacturer Narrative

A sample was requested for investigation but could not be provided.Based on the provided data the hbsag conf test results for sample no 2 are valid and the reagent performed within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HBSAG CONFIRMATORY TEST
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9133604
• MDR Text Key: 219214814
• Report Number: 1823260-2019-03485
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: P990012
• 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: 02/21/2020

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: ASKU
• Device Lot Number: 37329503
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 09/03/2019; 09/03/2019
• Supplement Dates FDA Received: 09/30/2019; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR