MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number	07026773190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-hav igm results for 1 patient sample on a cobas e 801 analytical unit compare to an abbott cmia analyzer.On (b)(6) 2023, the elecsys anti-hav igm result was 1.20 coi, interpreted as reactive.On (b)(6) 2023, the abbott anti-hav igm result was 0.6 coi, interpreted as non-reactive.On (b)(6) 2023, an aliquot of the original sample was repeated on the e801 analyzer again twice.The results were 1.23 coi and 1.17 coi, both interpreted as reactive.The initial reactive result was reported outside of the laboratory.The non-reactive result was deemed correct.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The patient sample was provided for investigation.The customer's reactive a-hav igm result could be reproduced.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc data provided was acceptable.The alarm trace did not contain a conspicuous event.The investigation determined that there was no evidence of a potential interference or cross-reactivity in the patient sample.The sample is considered reactive when tested with the elecsys anti-hav igm assay which is consistent with the increased sensitivity of the elecsys assay in comparison to the competitor assay used.The reactive result was confirmed with the elecsys anti-hav ii assay.A reagent issue was not identified.

• Brand Name: ELECSYS ANTI-HAV IGM
• Common Device Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• 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: 16755835
• Report Number: 1823260-2023-01292
• Device Sequence Number: 16963339
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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: 07026773190
• Device Lot Number: 663999
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 06/29/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 06/16/2023; 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 Age: 46 YR
• Patient Sex: Male