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 06P01-55

Device Problem False Positive Result (1227)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Patient identifier complete: sid: (b)(6).This report is being filed on an international product, list number 6p01-55 that has a similar product distributed in the us, list number 6p01-60.

Event Description

The customer reported a (b)(6) alinity s hiv ag/ab combo result on a patient.Results provided: (b)(6) 2021, sid: (b)(6) = (b)(6), retested on (b)(6) 2021 = (b)(6), bio-rad elisa is (b)(6).No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed to alinity s, list 6p16 (irving, tx as manufacturing site) and submitted under manufacturer report number 1628664-2022-00004-00.All further information will be documented under mdr number 1628664-2022-00004-00.

Event Description

The customer reported a false repeat reactive alinity s hiv ag/ab combo result on a patient.Results provided: (b)(6) 2021 sid (b)(6) = 1.46 / 0.46 / 0.42 s/co, retested on (b)(6) 2021 = 1.13 / 1.11 / 0.15 / 0.19 s/co.No impact to patient 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
• 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 ; 2246682940
• MDR Report Key: 13085497
• MDR Text Key: 283974672
• Report Number: 3002809144-2021-00719
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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: 05/04/2022
• Device Catalogue Number: 06P01-55
• Device Lot Number: 29500BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/25/2021
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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, AS1084; ALNTY S SYSTEM, 06P16-01, AS1084