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

Catalog Number 07026838190

Device Problem False Positive Result (1227)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of false positive elecsys anti-hbe results for 1 patient sample on a cobas e 801 analytical unit.The initial result was 0.637 coi (reactive).The repeated result was 0.648 coi (reactive).Calibration was performed and the sample was retested.The results after calibration were 0.743 coi (reactive) and 0.718 coi (reactive).The results did not fit the clinical picture of the patient.The sample was tested using another method (abbott alinity) and the result was 2.06 (non-reactive).

Manufacturer Narrative

A sample from the patient was requested for investigation, but the customer declined to send one.The investigation could not identify a product problem.The reagent performs within specifications.Single false positive results can occur and are covered by the claimed specificity for anti-hbe assay.

• Brand Name: ELECSYS ANTI-HBE
• Type of Device: 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: 18873768
• MDR Text Key: 337360090
• Report Number: 1823260-2024-00720
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 04015630940134
• UDI-Public: 04015630940134
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: P190005/S002
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026838190
• Device Lot Number: 68937201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female