MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II; HEPATITIS B TEST

Catalog Number 08814856190

Device Problem False Negative Result (1225)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 8000 - cobas e 602 module is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys hbsag ii (hbsag ii) result from one patient sample tested on the cobas 8000 - cobas e 602 module.The reporter stated that the initial result was not reported outside of the laboratory as the result did not match the patient's clinical diagnosis alerting them to an issue with the result.The initial result from the module was 0.471 coi (non-reactive).The first repeat result from the module was 0.418 coi (non-reactive).The second repeat result from a mindray analyzer was 0.558 iu/ml (reactive).

Manufacturer Narrative

The patient sample was not received for investigation.The investigation excluded a general reagent issue.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HBSAG II
• Type of Device: HEPATITIS B 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: 18837232
• MDR Text Key: 336896371
• Report Number: 1823260-2024-00651
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P160019
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08814856190
• Device Lot Number: 716367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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
• Patient Race: Asian