MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HIV AG/AB COMBO REAGENT KIT; HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES

Catalog Number	06P01-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient information, 1.Patient identifier = (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 repeat reactive alinity s hiv ag/ab combo results which nonreactive by the western blot hiv1 and hiv2 on multiple donors on multiple alinity s analyzer.The results provided were: on (b)(6) 2022 sid (b)(6) on (b)(4) initial=1.00 s/co (> or = 1.00 s/co=reactive) /repeated on (b)(6) 2022=4.25 s/co and 10.51 s/co.On (b)(6) 2022 sid (b)(6) on alinity (b)(4) initial=2.94 s/co /repeated on (b)(6) 2022=3.84 and 0.07 s/co (< 1.00 s/co=nonreactive).On (b)(6) 2022 sid (b)(6) on (b)(4) initial=2.86 s/co /repeated=4.48 s/co and 0.05 s/co there was no reported impact to patient management.
Additional 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, field data history of alinity s hiv ag/ab combo reagent, ln 6p01-60, lot number 42511be00.The ticket search determined that there is as expected complaint activity for the likely cause lots.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Overall reactive rates of ln 6p01-60, lot 42511be00 at biolife plasma services (social circle), 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 42511be00 are within product requirements and comparable to other lots analyzed in the comparison.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity s hiv ag/ab combo reagent, lot number 42511be00.
Event or Problem Description
The customer observed false repeat reactive alinity s hiv ag/ab combo results which nonreactive by the western blot hiv1 and hiv2 on multiple donors on multiple alinity s analyzer.The results provided were: on (b)(6) 2022 sid (b)(6) on as1285 initial = 1.00 s/co (> or = 1.00 s/co=reactive) /repeated on (b)(6) 2022 = 4.25 s/co and 10.51 s/co.On (b)(6) 2022 sid (b)(6) on alinity as1319 initial= 2.94 s/co /repeated on (b)(6) 2022=3.84 and 0.07 s/co (< 1.00 s/co = nonreactive).On (b)(6) 2022 sid (b)(6) on ali01319 initial= 2.86 s/co /repeated=4.48 s/co and 0.05 s/co additional information provided on 10feb2023: on (b)(6) 2023 sid (b)(6) on alinity as1322 initial = 11.59 s/co /repeated=9.61 s/co and 0.06 s/co additional information provided on 10feb2023: on (b)(6) 2023 sid (b)(6) on as1305 initial = 2.93 s/co /repeated = 8.41 s/co and 0.06 s/co.On (b)(6) 2023 sid (b)(6) on as1307 initial= 9.56 s/co /repeated = 4.34 s/co and 0.27 s/co.On (b)(6) 2023 sid (b)(6) on as1304 initial = 1.72 s/co /repeated = 6.28 s/co and 2.98 s/co.Additional information provided on 16feb2023: on (b)(6) 2023 sid (b)(6) on as1322 initial= 11.59 s/co /repeated = 9.61 s/co and 0.06 s/co.On (b)(6) 2023 sid (b)(6) on as1305 initial= 2.93 s/co /repeated = 8.41 s/co and 0.06 s/co.On (b)(6) 2023 sid (b)(6) on as1307 initial= 9.56 s/co /repeated = 4.34 s/co and 0.27 s/co.On (b)(6) 2023 sid (b)(6) on as1304 initial = 1.72 s/co /repeated = 6.28 s/co and 2.98 s/co there was no reported impact to patient management.
Event or Problem Description
The customer observed false repeat reactive alinity s hiv ag/ab combo results which nonreactive by the western blot hiv1 and hiv2 on multiple donors on multiple alinity s analyzer.The results provided were: on 12dec2022 sid (b)(6) on (b)(4) initial=1.00 s/co (> or = 1.00 s/co=reactive) /repeated on 13dec2022=4.25 s/co and 10.51 s/co on 15dec2022 sid (b)(6) on alinity (b)(4) initial=2.94 s/co /repeated on 16dec2022=3.84 and 0.07 s/co (< 1.00 s/co=nonreactive) on 16dec2022 sid (b)(6) on (b)(4) initial=2.86 s/co /repeated=4.48 s/co and 0.05 s/co additional information provided on 10feb2023: on 19jan2023 sid (b)(6) on alinity (b)(4) initial=11.59 s/co /repeated=9.61 s/co and 0.06 s/co there was no reported impact to patient management.
Additional Manufacturer Narrative
Updated section b5 describe event or problem: additional information provided on 10feb2023: on 19jan2023 sid (b)(6) on alinity (b)(4) initial=11.59 s/co /repeated=9.61 s/co and 0.06 s/co.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: ALINITY S HIV AG/AB COMBO REAGENT KIT
• Common Device Name: HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES
• 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: 16173606
• Report Number: 3002809144-2023-00035
• Device Sequence Number: 2331714
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125679
• 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,Followup
• Report Date (Section B): 03/23/2023

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: 07/09/2023
• Device Catalogue Number: 06P01-60
• Device Lot Number: 42511BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 02/10/2023; 03/20/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 03/02/2023; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, AS1285; ALNTY S SYSTEM, 06P16-01, AS1285; ALNTY S SYSTEM, 06P16-01, AS1285; ALNTY S SYSTEM, 06P16-01, AS1303; ALNTY S SYSTEM, 06P16-01, AS1304; ALNTY S SYSTEM, 06P16-01, AS1305; ALNTY S SYSTEM, 06P16-01, AS1307; ALNTY S SYSTEM, 06P16-01, AS1319; ALNTY S SYSTEM, 06P16-01, AS1319; ALNTY S SYSTEM, 06P16-01, AS1319; ALNTY S SYSTEM, 06P16-01, AS1322
• Patient Sex: Unknown