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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

No additional patient demographic information was provided.(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer identified (b)(6) alinity s hiv ag/ab combo results for one patient in comparison to another method.The following was provided: on (b)(6) 2021, sid (b)(6), initial result (b)(6).Repeated with another method (genetic systems (b)(6).Repeated with another method (panther) result (b)(6).The patient was noted as being a dcd (donor after cardiac death); the (b)(6) result precluded the donor from participation as a tissue donor.No further impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the alinity s hiv ag/ab combo reagent kit, list number (ln) 6p01-60, lot 20347be00.A review of tracking and trending did not identify any trends for the alinity s hiv ag/ab combo reagent, in regard to the customer issue.A customer data review for the alinity s hiv ag/ab combo, ln 6p01-60, lot 20347be00 was performed.The initial reactive rates (irr), repeat reactive rates (rrr), and specificity (assuming 0 prevalence) at gift of hope (goh), peer site, and across other available us customer sites were collected and assessed.Currently, goh has only one direct peer site where cadaveric samples are primarily tested.For both sites, due to the nature of the sample (cadaveric), the test data is limited for comparison.For lot 20347be00, the observed specificity at goh is 95.475% and is within the respective 95% confidence interval (ci) for cadaveric specimens documented in the package insert (95% ci: 93.51 ¿ 100%).With a larger cadaveric specimen sample size, the peer group site observed specificity is 99.214%.The overall irr, rrr and specificity of lot 20347be00 across other available us customer sites (excluding sites where cadaveric samples tested) are comparable to other lots of the same assay evaluated.The overall irr, rrr and specificity of all lots are within product requirements.Return testing was not completed as returns were not available.Manufacturing documentation was reviewed for the alinity s hiv ag/ab combo reagent, lot 20347be00 and no issues were identified.Additionally, labeling was reviewed and is found to sufficiently address the customer issue.Based on the investigation, the alinity s hiv ag/ab combo reagent ln 6p01-60, lot 20347be00 met performance specifications and performed as intended at the customer site; no systemic issue or deficiency was identified.

• 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
• MDR Report Key: 12297925
• MDR Text Key: 265841081
• Report Number: 3002809144-2021-00473
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117184
• UDI-Public: 00380740117184
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

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: 08/04/2021
• Device Catalogue Number: 06P01-60
• Device Lot Number: 20347BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1296; ALNTY S SYSTEM, 06P16-01, AS1296
• Patient Outcome(s): Disability
• Patient Age: 41 YR