MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST

Catalog Number	08086664190
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit (b)(6).The patient samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys anti-hav ii (anti-hav ii) results from five patient samples tested on the cobas e 801 analytical unit.Sample 1 on (b)(6) 2024: the initial result from the analyzer was 0.988 cut-off index coi (reactive) on (b)(6) 2024: the repeat result from another e801 analyzer was 1.02 coi (non-reactive).Sample 2 on (b)(6) 2024: the initial result from the analyzer was 0.943 coi (reactive) on (b)(6) 2024: the repeat result from another e801 analyzer was 1.01 coi (non-reactive).The repeat result from the analyzer was 0.985 coi (reactive).Sample 3 on (b)(6) 2024: the initial result was 0.611 coi (reactive) on (b)(6) 2024: the repeat result was 1.05 coi (non-reactive).Sample 4 on (b)(6) 2024: the initial result from the analyzer was 0.966 coi (reactive) on (b)(6) 2024: the repeat result from another e801 analyzer was 1.05 coi (non-reactive).The repeat result from the analyzer was 1.00 coi (reactive).Sample 5 on (b)(6) 2024: the initial result from the analyzer was 0.993 coi (reactive).The first repeat result from the analyzer was 0.984 coi (reactive).The second repeat result from the other e801 analyzer was 1.05 coi (non-reactive).The third repeat result from the other e801 analyzer was 1.06 coi (non-reactive).The fourth repeat result from the analyzer was 0.984 coi (reactive).The clinicians deemed the non-reactive results correct.
Additional Manufacturer Narrative
The patient samples were not received for investigation.The investigation reviewed the calibration data and the results were within specifications.The investigation reviewed the qc data.On 10-sep-2024, qc level 1 was within range; qc level 2 had two low results with data flags within 2 hours and 4 measurements.On 11-sep-2024, both qc levels were within specifications.On 26-sep-2024, the qc was 1.29 cut-off index coi (with a range of 1.52 coi to 1.06 coi).The investigation reviewed the customer's handling of patient samples and noted that the customer uses 12 x 75 tubes for one site and uses an automatic preanalytic system on both sites with different centrifugation speeds.Product labeling states "list of standard containers specifications: 16 mm x 100 mm, 16 mm x 75 mm, 13 mm x 100 mm, 13 mm x 100 mm." the field service engineer (fse) replaced the measuring cells, performed yearly maintenance, and replaced the sample probe, reagent probe, and the sample probe liquid-level detection (lld) card.He also checked the bead mixers and gear pump pressure.The investigation determined the event for samples 1, 2, 4, and 5 was due to patient samples with results close to the cut-off value of 1.0 cut-off index co.For sample 3, the event was consistent with a pre-analytic issue at the customer site.Product labeling states "limitations of the procedure - for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation determined the assay performed according to specifications.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HAV II
• Common Device Name: HEPATITIS A 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: 20362347
• Report Number: 1823260-2024-02869
• Device Sequence Number: 9629039
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: K190428
• 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): 11/11/2024

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: 03/31/2025
• Device Catalogue Number: 08086664190
• Device Lot Number: 76802701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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