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	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) (total of 4 donor samples).All available patient information was 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 or Problem Description
The customer reported false reactive alinity s htlv i/ii results generated on the alinity s system for 4 cadaveric tissue donors.The following data was provided: (b)(6) 2024, sid (b)(6): initial htlv i/ii result = 3.19 s/co; repeat results = 3.58 and 4.35 s/co; immunoblot result = negative; tissue disposition = not provided.(b)(6) 2024, sid (b)(6): initial htlv i/ii result = 3.94 s/co; repeat results = 2.83 and 2.00 s/co; immunoblot result = negative; tissue disposition = not provided.(b)(6) 2024, sid (b)(6): initial htlv i/ii result = 4.17 s/co; repeat results = 4.40 and 4.44 s/co; immunoblot result = negative; tissue disposition = not provided.(b)(6) 2024, sid(b)(6): initial htlv i/ii result = 1.29 s/co; repeat results = 1.19 and 0.14 s/co; immunoblot result = negative; tissue disposition = not provided.There was no impact to patient 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, batch history 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.A search for similar complaints did not identify an increase in complaint activity for lot 55216be00.Ticket trending review did not identify any trends for the issue for the product.Device history review did not identify any nonconformances, potential nonconformances, or deviations associate with lot 55216be00 and complaint issue.Customer release testing and statistical process control (spc) charts were reviewed.No issues were identified during review of customer release testing and the spc charts identified no issues regarding the performance of alinity s htlv i/ii lot 55216be00.Overall reactive rates of lot 55216be00 across core (usa), applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma monitoring group the performance of lot 55216be00 is within product requirements and comparable to other lots analyzed in the comparison.At core (usa) and peer sites, the specificity performance of ln 6p07-60 lot 55216be00 is within package insert representative data confidence interval for cadaveric specimens.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation the alinity s htlv i/ii reagent lot 55216be00 is performing as intended, no systemic issue or deficiency of the alinity s htlv i/ii reagent was identified.
Event or Problem Description
The customer reported false reactive alinity s htlv i/ii results generated on the alinity s system for 4 cadaveric tissue donors.The following data was provided: (b)(6) 2024, sid (b)(6): initial htlv i/ii result = 3.19 s/co; repeat results = 3.58 and 4.35 s/co; immunoblot result = negative; tissue disposition = not provided.(b)(6) 2024, sid (b)(6): initial htlv i/ii result = 3.94 s/co; repeat results = 2.83 and 2.00 s/co; immunoblot result = negative; tissue disposition = not provided.(b)(6) 2024, sid (b)(6): initial htlv i/ii result = 4.17 s/co; repeat results = 4.40 and 4.44 s/co; immunoblot result = negative; tissue disposition = not provided.(b)(6) 2024, sid (b)(6): initial htlv i/ii result = 1.29 s/co; repeat results = 1.19 and 0.14 s/co; immunoblot result = negative; tissue disposition = not provided.There was no impact to patient management 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19620934
• Report Number: 3002809144-2024-00182
• Device Sequence Number: 8204694
• Product Code: QHM
• UDI-Device Identifier: 00380740117214
• UDI-Public: (01)00380740117214(17)241001(10)55216BE00
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 10/01/2024
• Device Catalogue Number: 06P07-60
• Device Lot Number: 55216BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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)(6) ; ALNTY S SYSTEM, 06P16-01, (B)(6)
• Patient Sex: Unknown