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	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifiers: sids = (b)(6).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 reactive alinity s anti-hbc results on multiple donors.The customer stated that seven donor samples tested reactive for anti-hbc in one day.The samples were recentrifuged, repeated and all the results remained reactive.The customer did not send the samples out for confirmation, however, the customer felt that it was an excessive number of reactive results.The following data was provided: sid (b)(6) initial result = reactive; repeat result = reactive.Sid (b)(6) initial result = reactive; repeat result = reactive.Sid (b)(6) initial result = reactive; repeat result = reactive.Sid (b)(6) initial result = reactive; repeat result = reactive.Sid (b)(6) initial result = reactive; repeat result = reactive.Sid (b)(6) initial result = reactive; repeat result = reactive.Sid (b)(6) initial result = reactive; repeat result = reactive.No impact to donor management was reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s anti-hbc results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, or deviations with lot 40478be00 and complaint issue.Labeling was reviewed and sufficiently addresses the complaint issue.The overall reactive rates of ln 6p06-60, lot 40478be00 across central california blood center (ccbc), 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 40478be00 is within product requirements and comparable to other lots analyzed in the comparison.All 6p06-60 blood screening customers: lot 40478be00: irr: 0.312%, rrr: 0.305%, irr - rrr: 0.006%, specificity: 99.695%.Peer sites: lot 40478be00: irr: 0.284%, rrr: 0.278%, irr - rrr: 0.006%, specificity: 99.722%.Customer site: lot 40478be00: irr: 0.378%, rrr: 0.367%, irr - rrr: 0.010%, specificity: 99.633%.Based on the information within the complaint record, the device met performance specifications at the customer site as all reactive rates were within product requirements.Based on this investigation, alinity s anti-hbc reagent lot 40478be00 is performing as expected, no systemic issue or deficiency of alinity s anti-hbc 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: 16384783
• Report Number: 3002809144-2023-00086
• Device Sequence Number: 5114507
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 08/04/2023
• Device Catalogue Number: 06P06-60
• Device Lot Number: 40478BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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)
• Patient Sex: Unknown