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 Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier: multiple = 41413200264 and 11502931192 patient information: no further information was provided.

Event Description

The customer obtained false repeat reactive alinity s hiv combo results for 2 samples.The following results were provided: sample id 41413200264: alinity 30.22, 27.13 and 24.56 s/co; wb indeterminate; nat negative sample id 11502931192: alinity 2.31, 2.07 and 2.01 s/co; wb negative/hiv-2 negative; nat negative no impact to patient/donor management was reported.

Manufacturer Narrative

Investigation of the customer's issue included a review of the complaint text, complaint activity, trending data device history and field data.Return testing was not completed as returns were not available.Review of complaint activity and trending reports did not identify any issues or trends related to the complaint issue.Device history review for the reagent lot did not identify any non-conformances, potential non-conformances or deviations.Labeling was reviewed and sufficiently addresses the customer's issue.Review of field data for alinity s hiv ag/ab combo, ln, 6p01-60, lot number 12630be00 showed an initial reactive rate of 0.06% and a repeat reactive rate of 0.04%.Assuming a zero prevalence of hiv infections, the specificity for the field data is calculated to be 99.96%, which met the product requirement.Further, the field data are comparable to study data referenced in the alinity s hiv ag/ab combo package insert, where the specificity was 99.92% with a 95% confidence interval of 99.87% to 99.96%.Based on the investigation, no systemic issue or deficiency of the alinity s hiv ag/ab combo, lot 12603be00 was identified.

Event Description

The customer obtained false repeat reactive alinity s hiv combo results for 2 samples.The following results were provided: sample id (b)(6): alinity 30.22, 27.13 and 24.56 s/co; wb indeterminate; nat negative sample id (b)(6): alinity 2.31, 2.07 and 2.01 s/co; wb negative/hiv-2 negative; nat negative no impact to patient/donor management was reported.

• 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: 11076702
• MDR Text Key: 223800898
• Report Number: 3002809144-2020-01211
• 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: 02/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2020
• Device Catalogue Number: 06P01-60
• Device Lot Number: 12630BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, AS1217; ALNTY S SYSTEM, 06P16-01, AS1217; ALNTY S SYSTEM, 06P16-01, AS1217