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

Device Problem False Positive Result (1227)

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

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) alinity s hiv ag/ab combo results generated on an alinity s system for two samples.The samples were from eye, cornea, and retina donors.The samples generated (b)(6) results via hiv-1 western blot.The following results were provided: sid (b)(6), initial result= (b)(6).Sample repeated the next day generating results (b)6).(b)(6) hiv-1 western blot.The repeat (b)(6) results eliminated the tissue/organs for transplant use.No impact to recipients was reported.

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 customer 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.Ticket and trending review determined no trends for the likely cause lot or complaint issue.Device history record review did not identify any potential non-conformances, non-conformances or deviations with the likely cause lot.A customer data review for alinity s hiv ag/ab combo, ln 6p01-60, lot 24562be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at mid america transplant svc (mats), cadaveric peer sites and across all customer sites using this lot.The specificity and reactive rate performance of lot 24562be00 at mats is within 95% confidence interval (ci) for cadaveric specimens documented in the package insert (95% ci: 93.51 ¿ 100%).Further, aggregated performance of lot 24562be00 across all customer sites using this lot is within product requirements and comparable to the performance of other lots of the same assay.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, the alinity s hiv ag/ab combo reagent log 24562be00 met performance specifications and performed as intended at the customer site.No systemic issue and/or product deficiency was identified.Supplemental 3002809144-2021-00714-02 and 3002809144-2021-00714-03 were inadvertently submitted with incorrect information in section h10.This supplemental report contains corrected information in section h10, section b1 adverse event/product problem, section b2 outcomes attributed to ae, and section h1 type of reportable event.This information is being corrected from the information provided in supplemental report 3002809144-2021-00714-01.

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 customer 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.Ticket and trending review determined no trends for the likely cause lot or complaint issue.Device history record review did not identify any potential non-conformances, non-conformances or deviations with the likely cause lot.A customer data review for alinity s hiv ag/ab combo, ln 6p01-60, lot 24562be00 was performed.The analysis included initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming zero prevalence) at mid america transplant svc (mats), cadaveric peer sites and across all customer sites using this lot.The specificity and reactive rate performance of lot 24562be00 at mats is within 95% confidence interval (ci) for cadaveric specimens documented in the package insert (95% ci: 93.51 ¿ 100%).Further, aggregated performance of lot 24562be00 across all customer sites using this lot is within product requirements and comparable to the performance of other lots of the same assay.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the alinity s hiv ag/ab combo reagent log 24562be00 was identified.Corrected information in g1: contact office first name, contact office last name, contact office address 1, contact office address 2, contact office city, contact office country, contact office postal code, contact office phone number, contact office fax number, contact office e-mail.

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 review, and field data review.Return testing was not completed as returns were not available.Data and information provided were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any issues or trends for the complaint lots.Device history record review did not identify any potential non-conformances, non-conformances or deviations associated with the likely cause lot.Historical performance was reviewed using data gathered from customers worldwide.The patient median data (divided into 3 groups) and cal f rlu mean were analyzed and compared to an established control limit and found to be within the established limits.Therefore, no unusual lot performance was identified.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, the device met performance specifications and performed as intended at the customer site.No systemic issue or deficiency of the architect stat troponin-i reagent lot 75304un21 was identified.Corrected information in section b1 adverse event/product problem, section b2 outcomes attributed to ae, and section h1 type of reportable event.The information in the supplemental report was incorrectly selected.

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 review, and field data review.Return testing was not completed as returns were not available.Data and information provided were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any issues or trends for the complaint lots.Device history record review did not identify any potential non-conformances, non-conformances or deviations associated with the likely cause lot.Historical performance was reviewed using data gathered from customers worldwide.The patient median data (divided into 3 groups) and cal f rlu mean were analyzed and compared to an established control limit and found to be within the established limits.Therefore, no unusual lot performance was identified.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, the device met performance specifications and performed as intended at the customer site.No systemic issue or deficiency of the architect stat troponin-i reagent lot 75304un21 was identified.Corrected information in section h10.

• Brand Name: ALINITY S HIV AG/AB COMBO REAGENT KIT
• Type of Device: 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, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13064065
• MDR Text Key: 283820555
• Report Number: 3002809144-2021-00714
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup,Followup
• Report Date: 03/28/2022

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: 12/10/2021
• Device Catalogue Number: 06P01-60
• Device Lot Number: 24562BE00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/09/2022; 03/09/2022; 03/09/2022; 03/25/2022
• Supplement Dates FDA Received: 03/09/2022; 03/09/2022; 03/09/2022; 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01, (B)(6).; ALNTY S SYSTEM, 06P16-01,(B)(6).
• Patient Outcome(s): Disability