MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC II; TEST, HEPATITIS B

Catalog Number 07374160190

Device Problem False Negative Result (1225)

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

Event Date 01/28/2023

Event Type  malfunction  

Manufacturer Narrative

Calibration and controls were acceptable.No reagent issue is observed.Upon review of the alarm trace, no relevant alarms were observed.The patient sample material was requested, but could not be provided.Based on product labeling, samples with a cutoff index > 1.0 are non-reactive with the elecsys anti hbc ii assay.These samples are considered negative for anti-hbc and do not need further testing.The investigation could not identify a product problem.The cause of the event could not be determined.Na.

Event Description

The initial reporter stated they received questionable non-reactive results for one patient sample tested with the elecsys anti-hbc gen.2 immunoassay on a cobas 8000 e 602 module (serial number (b)(4).No questionable results were reported outside of the laboratory.A previous sample of the patient collected on (b)(6) 2023, resulted in a "nucleic acid test (nat) - hiv,hcv, hbv" result of non-reactive when tested using the cobas s201 multiplex pcr method.The complained sample was initially tested twice on the e 602 analyzer with anti-hbc reagent lot 600333 on (b)(6) 2023, resulting in anti-hbc values of 2.23 coi (non-reactive) and 2.24 coi (non-reactive).The complained sample was tested using the abbott alinity ci-series anti-hbc method on 28-jan-2023, resulting in a value of 1.21 s/co (reactive).The complained sample was re-centrifuged and repeated twice on the e 602 analyzer with anti-hbc reagent lot 600333 on (b)(6) 2023, resulting in anti-hbc values of 2.23 coi (non-reactive) and 2.27 coi (non-reactive).The complained sample was tested using the vitros anti-hbc method on (b)(6) 2023, resulting in a value of 3.65 (negative).No units of measure were provided for this result.The complained sample was tested on the e 602 analyzer with anti-hbc reagent lot 633393 on (b)(6) 2023, resulting in an anti-hbc value of 2.31 coi (non-reactive).

Manufacturer Narrative

The component code has been updated.

• Brand Name: ELECSYS ANTI-HBC 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16496382
• MDR Text Key: 310882165
• Report Number: 1823260-2023-00702
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P100031
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07374160190
• Device Lot Number: 600333, 633393
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• 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
• Patient Age: 39 YR
• Patient Sex: Male