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

Catalog Number 09127127190

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's e 801 is (b)(6).The patient samples are not available for investigation.Patient 1's new sample was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable hbsag confirmatory elecsys results from two patient samples tested on the cobas e 801 module.The reporter stated that the patients are considered to be negative for hepatitis b.Sample 1: on (b)(6) 2023: patient 1: the hbsag confirmatory result was 50.500% (positive).The result of the hepatitis b virus polymerase chain reaction: hepatitis b virus - deoxyribose nucleic acid (hbvpcr: hbv-dna) test was "not detectable".On (b)(6) 2023: the hbsag confirmatory result was 21.200% (positive).Sample 2: on (b)(6) 2023: the hbsag confirmatory result was 28.500% (positive).

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18977159
• MDR Text Key: 338553674
• Report Number: 1823260-2024-00899
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 07613336175293
• UDI-Public: 07613336175293
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P990012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09127127190
• Device Lot Number: 72911601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• 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
• Patient Sequence Number: 1