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	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false repeat reactive alinity s htlv i/ii results for two donors.The customer stated both donors were tested with another method and negative results were obtained.The following data was provided: (b)(6)2023 sid (b)(6)initial result = reactive; repeat result = reactive another method = negative (b)(6)2023 sid (b)(6) initial result = reactive; repeat result = reactive another method = negative there was no impact to donor management reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: 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 repeat reactive alinity s htlv i/ii results for two donors.The customer stated both donors were tested with another method and negative results were obtained.The following data was provided: 12dec2023 sid (b)(6) initial result = reactive; repeat result = reactive another method = negative.13dec2023 sid (b)(6) initial result = reactive; repeat result = reactive another method = negative.There was no impact to donor management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record 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 without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.The overall performance of the alinity s htlv i/ii reagents in the field was reviewed using data gathered from customers worldwide.Initial reactive rates (irr), repeat reactive rates (rrr) and specificity observed for lot 50095be00 are within product requirements and comparable to other lots analyzed in the comparison.Whole blood and plasma screening monitoring group: irr: 0.050 %, rrr: 0.042 %, irr - rrr 0.008 %, specificity: 99.958 %.Peer sites: irr: 0.053 %, rrr: 0.046 %, irr - rrr 0.007 %, specificity: 99.954 %.Based on the investigation, no systemic issue or deficiency of the alinity s htlv i/ii reagent lot 50095be00 was identified.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18441443
• Report Number: 3002809144-2024-00003
• Device Sequence Number: 6930098
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: 00380740117214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/08/2024

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: 04/27/2024
• Device Catalogue Number: 06P07-60
• Device Lot Number: 50095BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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)(4) ; ALNTY S SYSTEM, 06P16-01, (B)(4)
• Patient Sex: Unknown