MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number	06P06-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier sids: (b)(6) 2023 (b)(6), (b)(6)2023 (b)(6) (b)(6) 2023 sid (b)(6) see mr# 3002809144-2023-00450 for other lot#.
Event or Problem Description
The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co.(b)(6) sid (b)(6)= 0.84 s/co.(b)(6) sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.
Additional Manufacturer Narrative
A complaint investigation for false nonreactive results for alinity s anti-hbc included a review of trending data, labeling, device history record, field data, and a complaint search.No customer returns were available for evaluation.The complaint data for the product identified normal complaint activity for the complaint issue and no trends were identified.Labeling review concluded the labeling adequately addresses the issue.A device history record review did not identify any non-conformances or deviations.Based on the results of this investigation, alinity s anti-hbc reagent, lot 49219be00 is performing as expected and no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported a false reactive alinity s anti-hbc result on a donor.In (b)(6) 2023 alinity was reactive; in (b)(6) 2023 was nonreactive; in (b)(6) 2023 was reactive, another laboratory was negative for anti-hbc.Results provided: (b)(6) 2023 sid (b)(6) = 1.06 / 1.06 / 1.06 s/co, (b)(6) 2023 sid (b)(6) = 0.84 s/co, (b)(6) 2023 sid (b)(6) = 1.05 / 1.02 / 1.02 s/co.No impact to donor management was reported.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Common Device Name: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18067586
• Report Number: 3002809144-2023-00457
• Device Sequence Number: 7815464
• Product Code: QHM
• UDI-Device Identifier: 00380740117207
• UDI-Public: 00380740117207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BL125681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2024
• Device Catalogue Number: 06P06-60
• Device Lot Number: 49219BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, (B)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown