MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY S HBSAG REAGENT KIT; ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)

Catalog Number 06P02-60

Device Problem False Positive Result (1227)

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

Event Date 12/19/2022

Event Type  Injury  

Event Description

The customer observed false repeat reactive alinity s hbsag results for a cadaveric tissue donor samples that were nat negative.The results provided were: on (b)(6) 2022 sid (b)(6) initial=1.09 s/co (> or = 1.00 s/co=reactive) /repeated=1.11 s/co and 1.15 s/co, hemolysis was positive the tissue was discarded for all impacted sids.No additional impact to patient management was reported.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false repeat reactive alinity s hbsag results for a cadaveric tissue donor samples that were nat negative.The results provided were: on (b)(6) 2022 sid: (b)(4) initial=1.09 s/co (> or = 1.00 s/co=reactive) /repeated=1.11 s/co and 1.15 s/co, hemolysis was positive sid: (b)(4) initial=2.41 s/co /repeated=2.40 s/co and 2.53 s/co, hemolysis was positive.The tissue was discarded for all impacted sids.No additional impact to patient management was reported.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for alinity hbsag assay, list number (ln) 6p02-60, lot 36342fn00.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.The evaluation of complaint data for the product and likely cause alinity hbsag assay, lot 36342fn00 identified as expected activity.The tracking and trending report review determined that there are no trends.A review of ticket trending was performed and did not identify any trends.A review of labeling was also performed and concluded that the issue is sufficiently addressed.The performance of the alinity s hbsag reagent lot 36342fn00 was investigated by completing a review in the capa system for non-conformances, potential non-conformances and deviations related to the lot; there were no events or issues found that may have impacted the performance of the lot number in relation to the complaint issue.A cross functional team (cft) consisting of medical affairs, quality and technical operations reviewed and determined the adverse event was related to correct use, and concluded risk management file (rmf) is adequate and sufficiently addresses the issue under review.A technical review of field data for alinity s hbsag was also performed.The review consisted of looking at the overall reactive rates of ln 6p02-60, lot 36342fn00 across core, applicable peer sites and across all us customer sites.It was noted that across all us customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 36342fn00 is within product requirements, within package insert representative data for cadaveric specimens and comparable to other lots analyzed in the comparison.Additionally, at core the performance of lot 36342fn00 was noted to be within package insert representative data for cadaveric specimens.Based on the results of the investigation, the alinity s hbsag, ln 6p02-60, lot 36342fn00, is performing as expected and the device met performance specifications at the customer site as all reactive rates were within product requirements respectively package insert representative data for cadaveric testing.Further, no systemic issue or product deficiency was identified for alinity s hbsag, reagent lot 36342fn00.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Type of Device: ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16059568
• MDR Text Key: 306245909
• Report Number: 3008344661-2022-00190
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740136819
• UDI-Public: 00380740136819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL 125674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Catalogue Number: 06P02-60
• Device Lot Number: 36342FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1346.; ALNTY S SYSTEM, 06P16-01, AS1346.
• Patient Outcome(s): Disability