MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II; TEST, HEPATITIS B

Catalog Number 08814848190

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas e801 analytical unit serial number was (b)(6).Calibration and qc were acceptable.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's blood sample tested with elecsys hepatitis b surface antigen - hbsag g2 (hbsag ii) assay on a cobas e801 immunoassay analyzer when compared to a competitor's (abbott) platform.On (b)(6) 2024: initial result: 0.338 coi (non-reactive).1st repeat result: 0.278 coi (non-reactive).On (b)(6) 2024: the original sample was tested with dna testing and resulted in <5.00e+01 iu/ml (undetectable / negative).This result was reported outside the laboratory.On (b)(6) 2024: 3rd repeat result: 0.07 iu/ml (the original sample was tested on the abbott platform and was interpreted as reactive).The patient was diagnosed with a triple positive pattern of hepatitis b in another hospital in (b)(6) 2023 and was treated with the related drug treatment.

Manufacturer Narrative

The negative hbv dna result was in line with the non-reactive elecsys hbsag ii result.The investigation determined that the non-reactive elecsys hbsagii result was correct.The investigation did not identify a product problem.The elecsys hbsagii assay performs within specifications.

• Brand Name: ELECSYS HBSAG II
• Type of Device: TEST, HEPATITIS B
• 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: 18641455
• MDR Text Key: 334625656
• Report Number: 1823260-2024-00323
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P160019
• 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,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08814848190
• Device Lot Number: 701548
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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
• Treatment: ATORVASTATIN CALCIUM TABLETS.; BICYCLOL.; CALCITRIOL SOFT CAPSULES.; COMPOUND BETAMETHASONE INJECTION.; ENTECAVIR TABLETS.; ETORICOXIB TABLETS.; FELODIPINE EXTENDED-RELEASE TABLETS.; METHOTREXATE FOR INJECTION.; URSODEOXYCHOLIC ACID TABLETS.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian