MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HIV AG/AB COMBO; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Catalog Number 08P07-77

Device Problem False Positive Result (1227)

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

Event Date 06/03/2020

Event Type  Injury  

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.This report is being filed on an international product, list number 8p07-77 that has a similar product distributed in the us, list number 8p07-31.

Event Description

The customer reported a (b)(6) alinity i hiv ag/ab result on a (b)(6)-yr old female hemodialysis patient with chronic kidney disease stage 5.Results provided: (b)(6) 2020 = (b)(6), architect = (b)(6); elisa and cdc testing were (b)(6).The customer was dialyzed on a designated infectious disease dialysis machine due to the (b)(6) result generated.The patient did not receive any other treatment due to the (b)(6) result.

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.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.Inhouse testing determined that the specificity performance of the complaint lot is not negatively impacted.Labelling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i hiv ag/ab combo reagent lot 06105be01 was identified.

• Brand Name: ALINITY I HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10232509
• MDR Text Key: 198870502
• Report Number: 3002809144-2020-00545
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: 08P07-77
• Device Lot Number: 06105BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE LIST 03R65-01; ALINITY I PROCESSING MODULE LIST 03R65-01; SERIAL (B)(6); SERIAL (B)(6)
• Patient Outcome(s): Other
• Patient Age: 51 YR