MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC II; HEPATITIS B TEST (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 09109463190

Device Problem False Negative Result (1225)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas 8000 cobas e602 module serial number was (b)(6).Calibration and qc were performed and they were acceptable.Investigation is ongoing.

Event Description

We received an allegation about questionable results for 3 patients' samples tested with elecsys anti-hbc gen.2 (anti-hbc ii) assay on a cobas 8000 cobas e602 module.Patient 1: on (b)(6) 2023: anti-hbc index result: 0.15 coi (positive).On (b)(6) 2023: anti-hbc index result: 0.18 coi (positive).Pcr result: positive.(b)(6) 2023: anti-hbc index result: 0.154 coi (positive and tested with a lot number: 664160).Anti-hbc index result: 0.178 coi (tested with a lot number: 700427).Patient 2: on (b)(6) 2023: pcr result: positive.On (b)(6) 2023: anti-hbc index result: 2.14 coi (negative).Patient 3: on (b)(6) 2023: anti-hbc index result: 0.87 coi (positive).Pcr result: undetected (negative).(b)(6) 2023: anti-hbc index result: 0.926 coi (positive and tested with a lot number: 664160).Anti-hbc index result: 0.910 coi (tested with a lot number: 700427).

Manufacturer Narrative

The patient samples were received for investigation.The investigation retested the patient samples anti-hbc assay using reagent lot number 664160.The patient samples were run on a cobas e 602.The results are: patient 1: 0.895 coi (reactive) - the investigation was able to reproduce the customer's result.Patient 2: 0.113 coi (reactive) - the investigation was not able to reproduce the customer's result.Patient 3: 1.9 coi (non-reactive) - the investigation was not able to reproduce the customer's result.The patient samples were also sent to an external laboratory that uses an abbott alinity.The results are: patient 1: negative , patient 2: positive , patient 3: negative.For patient 1, the investigation was able to reproduce the customer's result but both results were discrepant with the external laboratory's result.For patient 2, the investigation determined the customer's results may be a false negative as the reruns at the investigation and external laboratories showed a positive result which corresponds to the positive hbv pcr result at the customer site.For patient 3, the investigation determined the customer's results may be a false positive as the reruns at the investigation and external laboratories showed a negative result which corresponds to the negative hbv pcr result at the customer site.The investigation reviewed the calibration data; the results were within specifications.The investigation reviewed the qc data; the results were within the specified range of +/- 3 standard deviations (sd).The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HBC II
• Type of Device: HEPATITIS B TEST (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: 17643780
• MDR Text Key: 322200018
• Report Number: 1823260-2023-02801
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: P100032
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 09109463190
• Device Lot Number: 66416001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• 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