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

Catalog Number	08086630190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples were requested for investigation.H3 other text : na.
Event or Problem Description
The initial reporter questioned positive results for "several" patient samples tested for elecsys anti-hav ii (anti-hav ii) using reagent lot 625986 on a cobas e 411 immunoassay analyzer.The reporter also questioned results close to the cut-off with new reagent lot 695556.On (b)(6) 2023 sample id (b)(6) result with reagent lot 625986 was 1.00 coi (positive).On (b)(6) 2023 the result with reagent lot 695556 was 1.17 coi (negative).On (b)(6) 2023 sample id (b)(6) result with reagent lot 625986 was 0.89 coi (positive).On (b)(6) 2023 the result with reagent lot 695556 was 1.03 coi (negative).On (b)(6) 2023 sample id (b)(6) result with reagent lot 625986 was 0.95 coi (positive).On (b)(6) 2023 the result with reagent lot 695556 was 1.21 coi (negative).On (b)(6)2023 sample id (b)(6) result with reagent lot 625986 was 0.87 coi (positive).On (b)(6) 2023 the result with reagent lot 695556 was 1.01 coi (negative).The positive results were reported outside of the laboratory where they were questioned by the physician.The patients did not receive vaccination and are not known to have a hepatitis a infection.On (b)(6) 2023 samples from employees at the customer site were tested for troubleshooting purposes and compared to the abbott method.The results for 2 samples tested with reagent lot 625986 were positive and the abbott results were negative.Sample d.L.Result with reagent lot 625986 was 0.89 (positive).The result with reagent lot 695556 was 1.06 coi (negative).The result from the abbott method was 0.10 (negative).Sample k.T.Result with reagent lot 625986 was 0.99 coi (positive).The result with reagent lot 695556 was 1.21 coi (negative).The result from the abbott method was 0.06 (negative).The e411 analyzer serial number is (b)(6).
Additional Manufacturer Narrative
Sample id (b)(6) was tested using the abbott method and the anti-hav result was 0.76 (negative).Sample id (b)(6) was tested using the abbott method and the anti-hav result was 0.89 (negative).Sample id (b)(6) was tested using the abbott method and the anti-hav result was 0.09 (negative).Sample id (b)(6) was tested using the abbott method and the anti-hav result was 0.11 (negative).Samples (b)(6), d.L., and k.T.Were provided for investigation.The samples measured results near the cutoff of the roche anti-hav assay.Samle id (b)(6) was determined to be reactive (0,990 coi) with anti-hav reagent lot 625986, but non-reactive (1,03 coi) with anti-hav reagent lot 695556.All other samples were assessed equally with both lots.
Additional Manufacturer Narrative
Sample id (b)(6) also showed an increased result value in the abbott test (0.89 coi) and may contain a low antibody titer.The investigation determined the product was working within specifications.No product issues were found.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17145126
• Report Number: 1823260-2023-01989
• Device Sequence Number: 14892280
• Product Code: LOL
• UDI-Device Identifier: 07613336129722
• UDI-Public: 07613336129722
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 07/21/2023

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: 07/31/2023
• Device Catalogue Number: 08086630190
• Device Lot Number: 62598601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 07/18/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/13/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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