MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Catalog Number 08P07-32

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further information was provided.

Event Description

The customer obtained (b)(6) alinity i (b)(6) combo results for one patient.Sample id (b)(6) generated (b)(6) results of (b)(6) on the alinity and (b)(6) on nat assay.No impact to patient management was reported.

Event Description

The customer obtained false non-reactive alinity i hiv ag/ab combo results for one patient.Sample id (b)(6) generated non-reactive results of 0.1, 0.130 and 0.130 s/co on the alinity and positive on nat assay.No impact to patient management 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 inhouse testing of a retained kit of the complaint lot number.Return testing was not completed as returns were not available.Review of trending reports did not identify and trends associated with the issue.Device history record review for the reagent lot did not identify any non-conformances or deviations related to the complaint issue.Inhouse testing of a retained kit of reagent lot 22259be00 determined that the sensitivity performance of the complaint lot was not negatively impacted.Two commercially available seroconversion panels were tested with the complaint lot.The lot showed results comparable to the data provided by the manufacturer of the panels.Based on our investigation, no systemic issue or deficiency of alinity i hiv ag/ab combo reagent, lot number 22259be00 was identified.

• Brand Name: ALINITY I HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11076492
• MDR Text Key: 243766496
• Report Number: 3002809144-2020-01210
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: 08P07-32
• Device Lot Number: 22259BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI02957; ALNTY I PROCESSING MODU, 03R65-01, AI02957