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

Catalog Number 08814848190

Device Problem False Positive Result (1227)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

The initial reporter questioned the results for 1 patient tested for elecsys hbsag ii (hbsag ii) on a cobas e 801 analytical unit.On (b)(6) 2023 the result was 4.85 coi (positive).On (b)(6) 2023 a new sample was obtained and the result was 0.43 coi (negative).The customer questions how the result could change from positive to negative in this timeframe; the results did not seem "normal" from a clinical perspective.The samples were not available for repeat testing.It is not clear which result was believed to be correct.The results were reported outside of the laboratory.The e801 module serial number was (b)(6).

Manufacturer Narrative

Calibration and qc were acceptable.No sample material was available for investigation.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: TEST, HEPATITIS B
• 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: 17016410
• MDR Text Key: 317443548
• Report Number: 1823260-2023-01765
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 07613336168103
• UDI-Public: 07613336168103
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08814848190
• Device Lot Number: 123456
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• 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