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	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned positive results for multiple patient samples tested for elecsys anti-hav ii (anti-hav ii) between (b)(6) 2022 and (b)(6) 2022 on a cobas e 411 immunoassay analyzer.The following are examples of positive results for 5 patient samples: (b)(6).The customer repeated the samples on the same analyzer and obtained the same positive results.The customer has not repeated the samples by another method.The customer alleges the results for these patients are "false" positive.Clarification has been requested as to why the positive results are in question, however, clarification has not been received.No questionable results were reported outside of the laboratory.The e411 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Section b3, date of event was updated.
Additional Manufacturer Narrative
No issues were identified with the calibration and qc data provided.The customer did not provide any additional information as to why their anti-hav ii result should have been negative.The customer's sample was requested for investigation but was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
Clarification was received as to why the customer believes the anti-hav ii results were "false" positive.The customer tested herself for anti-hav ii and obtained a positive result but she knows she should be negative.This prompted the customer to repeat multiple patient samples with positive results to confirm the results.

• 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: 14876034
• Report Number: 1823260-2022-01921
• Device Sequence Number: 5098596
• Product Code: LOL
• UDI-Device Identifier: 07613336129722
• UDI-Public: 07613336129722
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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,Followup
• Report Date (Section B): 08/29/2022

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: 08/31/2022
• Device Catalogue Number: 08086630190
• Device Lot Number: 545371
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 07/11/2022; 08/02/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/15/2022; 08/04/2022; 08/29/2022
• 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