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

Catalog Number 07P51-20

Device Problem False Negative Result (1225)

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

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed b-hcg results on the alinity analyzer.The following data was provided: sid (b)(6) initial <2.3 ((b)(6) 2019) sid (b)(6) (a new sample taken (b)(6) 2020) initial 100,410.The patient was confirmed to be gestational age of (b)(6) in a scan.There was no negative impact to patient management.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 06112ui00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing protocol was executed using retained samples of lot 06112ui00.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 complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect total b-hcg for lot 06112ui00 was identified.

• Brand Name: ALINITY I TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9667302
• MDR Text Key: 205515883
• Report Number: 3005094123-2020-00033
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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?: Yes
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY ANALYZER; ALINITY ANALYZER; LN 03R65-01 SN (B)(6) ; LN 03R65-01 SN (B)(6)