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	03/13/2023
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer stated that alinity s hiv ag/ab combo results of 1.62 s/co (reactive), 0.08 s/co (nonreactive) and 5.66 s/co (reactive) were generated for a patient (sample id (b)(6)) on (b)(6) 2023.Western blot testing was negative for hiv i/ii.No impact to patient/donor management was reported.
Event or Problem Description
The customer stated that alinity s hiv ag/ab combo results of 1.62 s/co (reactive), 0.08 s/co (nonreactive) and 5.66 s/co (reactive) were generated for a patient (sample id (b)(6)) on (b)(6) 2023.Western blot testing was negative for hiv i/ii.No impact to patient/donor management was reported.
Additional Manufacturer Narrative
Per the complaint documentation, the customer observation was consistent with non-specific binding potentially associated with sample integrity issues and therefore a member of the abbott customer experience team visited the site to observe and review pre-analytics processes.The outcomes of the review were communicated to the customer and are intended to optimize these processes to mitigate influences related to the integrity of the samples.The customer confirmed their understanding of how pre-analytics processes can impact sample integrity.Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.A technical review of field data for alinity s hiv ag/ab combo was performed.Overall reactive rates for lot 46383be00 for the customer site, 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 customer and their peer sites, the performance for lot 46383be00 is within product requirements and comparable to other lots analyzed in the comparison.Based on the investigation, no malfunction or deficiency for lot number 46383be00 was identified.
Additional Manufacturer Narrative
On april 17, 2023 after submitting the initial emdr, it was discovered that field g3 (date received by mfg) was entered incorrectly as 3/6/2023.The falsely reactive alinity s hiv ag/ab combo results were not generated until 3/13/2023.The correct date for field g3 should be 3/30/2023.

• 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: 16755733
• Report Number: 3002809144-2023-00194
• Device Sequence Number: 18274756
• 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): 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: 10/07/2023
• Device Catalogue Number: 06P01-60
• Device Lot Number: 46383BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 06/23/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 04/17/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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, AS1230; ALNTY S SYSTEM, 06P16-01, AS1230; ALNTY S SYSTEM, 06P16-01, AS1230
• Patient Sex: Unknown