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

Catalog Number	08086630190
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e601 analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable positive results for an unspecified number of patient samples tested with elecsys anti-hav ii on a cobas 6000 e601 module.A doctor complained that the results did not agree with the clinical status of the patients.The patients did not receive vaccination for hepatitis a and also had no known hepatitis a infection.The customer stated patient samples will recover anti-hav values of 0.96 coi (reactive), 0.97 coi (reactive), or 0.99 coi (reactive) for example.These samples were repeated and the values were still positive.
Additional Manufacturer Narrative
Sample from the patient was requested for further investigation, but none was available.Several lots of elecsys ahav ii (including lot 695556) were checked by a comparison study and all reagent lots performed within specifications.It was determined the elecsys ahav ii assay performs within specification.

• 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: 18327177
• Report Number: 1823260-2023-03999
• Device Sequence Number: 15212414
• Product Code: LOL
• UDI-Device Identifier: 07613336129722
• UDI-Public: 07613336129722
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 12/20/2023

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 Catalogue Number: 08086630190
• Device Lot Number: 695556
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 12/21/2023
• 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