MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBS II; HEPATITIS B TEST

Catalog Number 08498610190

Device Problem False Positive Result (1227)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The samples were requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of false positive elecsys anti-hbs ii results for 1 patient on a cobas e 801 analytical unit.The hbsag result was 8.25 coi (positive).The anti-hbs result was 51 iu/l.The a-hbc result was 0.01 coi (positive) on (b)(6) 2024 the patient results were: the hbsag result was 7.75 coi (positive).The anti-hbs result was 40 iu/l.The a-hbc: result was 0.01 coi (positive).A competitor's method was used (attelica) and the results were: the hbsag result was positive.The a-hbs result was negative.The a-hbc result was positive.Numerical results for the competitor's method were not provided.

Manufacturer Narrative

Two samples were received for investigation on 28-mar-2024.The samples were tested on a cobas e 801 and a cobas pro with cir retention kits.Investigation results: sample 1: the anti-hbs ii result was 44.4 iu/l.The anti-hbc ii result was 0.00707 coi reactive.The hbsag ii result was 9.16 coi reactive.Sample 2: the anti-hbs ii result was 45.3 iu/l.The anti-hbc ii result was 0.00714 coi reactive.The hbsag ii result was 9.42 coi reactive.The positive anti-hbs ii result was reproduced during the investigation.Therefore, the positive anti-hbs ii result is assumed to be unspecific/false positive.A (lot independent) interference is most likely.Product labeling states: "individuals that have received blood component therapy, e.G.Whole blood, plasma, immune globulin administration, during the previous 3 to 6 months may have a false reactive anti-hbs result due to passive transfer of anti-hbs." the reagent performed within specification.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HBS 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: 19021420
• MDR Text Key: 339136662
• Report Number: 1823260-2024-01009
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P190034
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08498610190
• Device Lot Number: 716600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• 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