MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S HTLV I/II REAGENT KIT; HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II (E COLI, RECOM) AG AND SYNTH PEPTIDES

Catalog Number	06P07-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
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: patient identifier sids: (b)(6).
Event or Problem Description
The customer reported false repeat reactive alinity s htlv i/ii results on multiple donors.Results provided: sid: initial repeat western blot (b)(6): reactive reactive / reactive neg (b)(6): reactive reactive / non-reactive neg (b)(6): reactive reactive / non-reactive neg (b)(6): reactive reactive / reactive neg (b)(6) :reactive reactive / reactive indeterminate no impact to donor management was reported.
Additional Manufacturer Narrative
A complaint investigation for an increase in reactive rates and potential false reactive results for alinity s htlv-i/htlv-ii reagent 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.A review of field data for the overall performance of the alinity s htlv-i/htlv-ii reagent indicated the product was performing within product requirements.For lot 46236be00, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed is within product requirements and comparable to other lots analyzed in the comparison.Based on the results of this investigation, alinity s htlv-i/htlv-ii reagent, lot 46236be00 is performing as expected and no systemic issue or product deficiency was identified.Section a1 patient identifier sids: (b)(6).
Event or Problem Description
The customer reported false repeat reactive alinity s htlv i/ii results on multiple donors.Results provided: sid date initial / repeat western blot.(b)(6) 03mar2023 = 2.01 / 1.9 / 2.01 n.(b)(6) 03mar2023 = 1.01 / 1.06 n.(b)(6) 03mar2023 = 1.13 / 1.15 n.(b)(6) 05mar2023 = 1.29 / 1.24 / 1.26 n.(b)(6) 07mar2023 = 1.21 / 1.18 / 1.18 indt.(b)(6) 24mar2023 = 3.31 / 2.87 / 3.24 n.(b)(6) 11mar2023 = 1.57 / 1.57 / 1.6 n.(b)(6) 11mar2023 = 1.55 / 1.36 / 1.46 n.(b)(6) 10mar2023 = 1.18 / 1.02 / 1.02 n.(b)(6) 08mar2023 = 2.19 / 2.2 / 2.09 n.(b)(6) 08mar2023 = 1.1 / 1.04 / 1.12 n.(b)(6) 14mar2023 = 1.17 / 1.13 / 1.14 n.(b)(6) 14mar2023 = 1.18 / 1.13 / 1.15 n.(b)(6) 08mar2023 = 1.27 / 1.30 / 1.31 n.(b)(6) 29mar2023 = 1.07 / 1.01 indt.(b)(6) 10mar2023 = 1.07 / 1.03 indt.(b)(6) 11mar2023 = 2.54 / 2.62 / 2.72 indt.(b)(6) 26mar2023 = 7.08 / 7.32 / 8.14 indt.Uom = s/co.No impact to donor management was reported.
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).
Event or Problem Description
The customer reported false repeat reactive alinity s htlv i/ii results on multiple donors.Results provided: sid date initial / repeat western blot (b)(6) 03mar2023 = 2.01 / 1.9 / 2.01 n (b)(6) 03mar2023 = 1.01 / 1.06 n (b)(6) 03mar2023 = 1.13 / 1.15 n (b)(6) 05mar2023 = 1.29 / 1.24 / 1.26 n (b)(6) 07mar2023 = 1.21 / 1.18 / 1.18 indt (b)(6) 24mar2023 = 3.31 / 2.87 / 3.24 n (b)(6) 11mar2023 = 1.57 / 1.57 / 1.6 n (b)(6) 11mar2023 = 1.55 / 1.36 / 1.46 n (b)(6) 10mar2023 = 1.18 / 1.02 / 1.02 n (b)(6) 08mar2023 = 2.19 / 2.2 / 2.09 n (b)(6) 08mar2023 = 1.1 / 1.04 / 1.12 n (b)(6) 14mar2023 = 1.17 / 1.13 / 1.14 n (b)(6) 14mar2023 = 1.18 / 1.13 / 1.15 n (b)(6) 08mar2023 = 1.27 / 1.30 / 1.31 n (b)(6) 29mar2023 = 1.07 / 1.01 indt (b)(6) 10mar2023 = 1.07 / 1.03 indt (b)(6) 11mar2023 = 2.54 / 2.62 / 2.72 indt (b)(6) 26mar2023 = 7.08 / 7.32 / 8.14 indt uom = s/co.No impact to donor management was reported.

• Brand Name: ALINITY S HTLV I/II REAGENT KIT
• Common Device Name: HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II (E COLI, RECOM) AG AND SYNTH 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: 16688402
• Report Number: 3002809144-2023-00183
• Device Sequence Number: 5930907
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: 00380740117214
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125675
• 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): 06/23/2023

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: 10/24/2023
• Device Catalogue Number: 06P07-60
• Device Lot Number: 46236BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 06/23/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/16/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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, AS1240, AS1241; ALNTY S SYSTEM, 06P16-01, AS1240, AS1241; ALNTY S SYSTEM, 06P16-01, AS1240, AS1241
• Patient Sex: Unknown