MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC II; HEPATITIS B TEST (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07026790190

Device Problem False Negative Result (1225)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas e 801 analytical unit is (b)(6).The customer stated that the patient sample was initially run in line 1 of the module and there were no alarms noted; and that when it was run on line 2, the module detected foam in the patient sample.The investigation reviewed the images from the foam detection camera.The investigation noted that the camera in line 1 was not able to detect the foam because of the position of the bubble.Product labeling states "avoid foam formation in all reagents and sample types (specimens, calibrators and control)." the investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys anti-hbc immunoassay result from one patient sample tested on the cobas e 801 analytical unit.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 customer stated that the patient sample was initially run in line 1 of the module and there were no alarms noted; and that when it was run on line 2, the module detected foam in the patient sample and the analyzer did not give any result.The reporter reran the patient sample again.The initial result was (b)(4) cut-off index (coi) with an interpretation of "non-reactive/negative".The repeat result was (b)(4) coi with an interpretation of "reactive/positive".

Manufacturer Narrative

The investigation reviewed the customer's handling of patient samples; no issues were noted.The investigation determined the event was caused by bubbles in the patient sample.Product labeling states "incorrect results may occur due to foam, fibrin clots, films, or air bubbles in reagents or samples.Avoid the formation of foam, clots, and air bubbles in all reagents, samples, calibrators, and qc material." the investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HBC II
• Type of Device: HEPATITIS B TEST (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• 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: 17797262
• MDR Text Key: 324017024
• Report Number: 1823260-2023-03057
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P100032
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 07026790190
• Device Lot Number: 69577901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• 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
• Patient Race: Asian