MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBE; ANTI-HBE TEST

Catalog Number	07026838190
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation reviewed the anti-hbe qc data.The customer's qc results were within specifications but slightly higher on (b)(6) 2024 than the previous days.It was not clear which reagent and qc combination was used.The recovery of all internal qc samples of the release panel is completely within the specification and overall, completely comparable.The reagent lot number 758799 showed only a slightly higher recovery compared to lot 689372.The sensitivity of both lots was completely comparable and completely within specifications.The global data showed that the recovery of both lots was completely comparable for both levels of control.The investigation reviewed the calibration data for both reagent lots 689372 and 758799 and the results were within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The lot number of elecsys anti-hbe reagent lot a is 689372.The lot number of elecsys anti-hbe reagent lot b is 758799.The serial number of the customer's cobas 8000 core unit 2145-02.The investigation is ongoing.E1 initial reporter street line 2: no.145 shandong road central, huangpu district.
Event or Problem Description
The initial reporter received questionable elecsys anti-hbe (anti-hbe) results from two patient samples tested on the cobas 8000 core unit.The reporter was comparing the performance of the assay's two reagent lots: reagent lot a (old reagent lot) and reagent lot b (new reagent lot).The initial positive results were reported outside of the laboratory.The reporter considered the initial positive results incorrect.Sample id (b)(6) on (b)(6) 2024: the initial result from the analyzer using reagent lot a was 0.850 cut-off index coi (positive).On (b)(6) 2024: the first repeat result from the analyzer using reagent lot b was 1.09 coi (negative).The second repeat result from the analyzer using reagent lot b after centrifugation and recalibration was 1.09 coi (negative).On (b)(6) 2024: the third repeat result from another laboratory using reagent lot b was 1.05 coi (negative).The fourth repeat result from another laboratory using reagent lot b was 1.04 coi (negative).Sample id (b)(6) on (b)(6) 2024: the initial result from the analyzer using reagent lot a was 0.866 rounded off to 0.87 coi (positive).On (b)(6) 2024: the first repeat result from the analyzer using reagent lot b was 1.02 coi (negative).The second repeat result from the analyzer using reagent lot b after centrifugation and recalibration was 1.02 coi (negative).On (b)(6) 2024: the third repeat result from another laboratory using reagent lot b was 1.00 coi (negative).The fourth repeat result from another laboratory using reagent lot b was 1.02 coi (negative).The reporter would like to know if the newer lot gave higher results.

• Brand Name: ELECSYS ANTI-HBE
• Common Device Name: ANTI-HBE TEST
• 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: 19247180
• Report Number: 1823260-2024-01352
• Device Sequence Number: 7244067
• Product Code: LOM
• UDI-Device Identifier: 04015630940134
• UDI-Public: 04015630940134
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P190005/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 07026838190
• Device Lot Number: 689372, 758799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown