MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBE; ANTI-HBE TEST

Catalog Number	07026838190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).The competitor method is abbott.
Event or Problem Description
The initial reporter questioned positive results from 2 samples from 1 patient tested for elecsys anti-hbe (anti-hbe) on a cobas pure e 402 analytical unit.On (b)(6) 2023 the result from the e402 analyzer was (b)(6) (positive).The sample was sent to a reference laboratory where the result from a competitor method was "negative." the actual result was not provided.On (b)(6) 2023 the result from the e402 analyzer was positive.The actual result was not provided.
Additional Manufacturer Narrative
Section b3 was updated.The initial report stated: "on (b)(6) 2023 the result from the e402 analyzer was 0.19 coi (positive)." this should say: "on (b)(6) 2023 the result from the e402 analyzer was 0.19 coi (positive)." the result from the e402 analyzer from 06-dec-2023 was provided: on (b)(6) 2023 the result from the e402 analyzer was 0.18 coi (positive).Section b6 was updated.
Additional Manufacturer Narrative
The customer questioned a positive result for an additional patient sample (patient 2) tested for anti-hbe.The result from the e402 analyzer was 0.44 coi (positive).The sample was sent to a reference laboratory where the result by the abbott architect method was "negative." the specific result was not provided.Sample material for patient 1 was submitted for investigation.The sample for patient 2 was not submitted for investigation.For patient 1: the sample was tested on an e402 analyzer with 2 anti-hbe reagent lots (689372 and 758799).The customer's positive results were reproduced: reagent lot 689372: 0.184 coi (positive).Reagent lot 758799: 0.164 coi (positive).The sample was investigated further and it was determined the elecsys anti-hbe was correctly positive.A general reagent or lot-specific issue was not identified.The reagent performs within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HBE
• Common Device Name: ANTI-HBE 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: 18477034
• Report Number: 1823260-2024-00102
• Device Sequence Number: 12498682
• Product Code: LOM
• UDI-Device Identifier: 04015630940134
• UDI-Public: 04015630940134
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: P190005/S002
• 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): 05/08/2024

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: 09/30/2024
• Device Catalogue Number: 07026838190
• Device Lot Number: 689372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 04/24/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/01/2024; 05/08/2024
• 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