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	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hbc result on four samples when compared to the nat result.The following data was provided (reactive cutoff >1.00 s/co): sid (b)(6) alinity s anti-hbc initial 7.99 s/co, repeated 8.34 and 8.15 s/co, panther nat ultrio elite nonreactive (0.10 s/co).Sid (b)(6) alinity s anti-hbc initial 3.79 s/co, repeated 3.53 and 3.76 s/co, panther nat ultrio elite nonreactive (0.08 s/co).Sid (b)(6) alinity s anti-hbc initial 5.32 s/co, repeated 5.77 and 5.68 s/co, panther nat ultrio elite nonreactive (0.13 s/co).Sid (b)(6) alinity s anti-hbc initial 1.06 s/co, repeated 1.06 and 1.14 s/co, panther nat ultrio elite nonreactive (0.09 s/co).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hbc result on four samples when compared to the nat result.The following data was provided (reactive cutoff >1.00 s/co): sid (b)(6).Alinity s anti-hbc initial 7.99 s/co, repeated 8.34 and 8.15 s/co, panther nat ultrio elite nonreactive (0.10 s/co).Sid (b)(6).Alinity s anti-hbc initial 3.79 s/co, repeated 3.53 and 3.76 s/co, panther nat ultrio elite nonreactive (0.08 s/co).Sid (b)(6).Alinity s anti-hbc initial 5.32 s/co, repeated 5.77 and 5.68 s/co, panther nat ultrio elite nonreactive (0.13 s/co).Sid (b)(6).Alinity s anti-hbc initial 1.06 s/co, repeated 1.06 and 1.14 s/co, panther nat ultrio elite nonreactive (0.09 s/co).No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed.Return testing was not performed as returns were not available.Device history record review was performed on lot 37332be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.Overall reactive rates of ln 6p06-60, lot 37332be00 across us naval hospital okinawa*, applicable peer sites and across all us customer sites were collected and assessed.Across all us blood screening customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 37332be00 is within product requirements and comparable to other lots analyzed in the comparison.Lot 37332be00: irr: 0.325%, rrr: 0.311%, irr - rrr: 0.013%, specificity: 99.689%.Peer sites: lot 37332be00: irr: 0.304%, rrr: 0.290%, irr - rrr: 0.013%, specificity: 99.710%.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation, alinity s anti-hbc reagent kit, ln 6p06-60, lot 37332be00 is performing as expected.Based on the information within the complaint record, the devices met performance specifications at the customer site as all reactive rates were within product requirements.
Additional Manufacturer Narrative
The investigation was re-reviewed.Based on the investigation, no systemic issue or deficiency of the alinity s anti-hbc assay was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16105000
• Report Number: 3002809144-2023-00013
• Device Sequence Number: 20746726
• Product Code: QHM
• UDI-Device Identifier: 00380740117207
• UDI-Public: 00380740117207
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/07/2024

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: 04/19/2023
• Device Catalogue Number: 06P06-60
• Device Lot Number: 37332BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 02/21/2023; 02/06/2024
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/22/2023; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown