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

Catalog Number 08086630190

Device Problems False Negative Result (1225); False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The patient sample was requested for investigation.The sample was received for investigation.The sample was tested using two different anti-hav reagent lots and the results were 0.881 coi and 0.902 coi, both interpreted as reactive.The investigation is ongoing.H3 other text : na.

Event Description

There was an allegation of questionable elecsys anti-hav gen.2 assay results for 1 patient sample on a cobas 6000 e601 module.The patient had an initial anti-hav result of 0.827 coi, interpreted as reactive.The patient sample was testing using another method and the result was non-reactive.The other testing method used was not provided.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The investigation determined that the patient's reactive anti-hav results are the correct results.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HAV II
• Type of Device: 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: 17270337
• MDR Text Key: 318659850
• Report Number: 1823260-2023-02190
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K190428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1