MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ALINITY I TOTAL B-HCG REAGENT KIT

Catalog Number 07P51-20

Device Problem False Positive Result (1227)

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

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.This report is being filed on an international product, list number 7p51-20 that has a similar product distributed in the us, list number 7p51-21.

Event Description

The customer reported false positive alinity i b-hcg results on one female patient who is taking roacutane.The results provided were: (b)(6) 2019 sid (b)(6) = 243.11iu/l (>/=25.00iu/l=positive) / retested on another alinity = positive / on roche method = positive / a new sample (unknown date) is tested = negative.There was no reported impact to patient management.

Manufacturer Narrative

The ticket search determined normal complaint activity for lot 06112ui00, and no trends were identified for the product.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 06112ui00 and all validity and acceptance criteria were met, demonstrating that this lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i total b-hcg reagent, lot 06112ui00.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Type of Device: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9756642
• MDR Text Key: 221030668
• Report Number: 3005094123-2020-00053
• Device Sequence Number: 1
• Product Code: DHA
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2020
• Device Catalogue Number: 07P51-20
• Device Lot Number: 06112UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; SERIAL # (B)(6) ; SERIAL # (B)(6)