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 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 07p51-20 that has a similar product distributed in the us, list number 7p51-21/31.

Event Description

The customer observed falsely depressed alinity i total beta-hcg reagent result for a patient.The following data was provided:(unit of measure:iu/l); initial = <2 (negative) on (b)(6) 2020, and the patient was redrawn on (b)(6) 2020 = 431524 (positive).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 in-house testing of the complaint lot.Review of complaint activity determined that there was normal complaint activity for reagent lot 08043ui00.Review of tracking and trending reports did not identify any related trends for the alinity i total b-hcg assay.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Testing of a retained kit of the complaint lot demonstrated that the lot performs acceptably.Based on our investigation, no systemic issue or deficiency of the alinity i total b-hcg assay for lot 08043ui00 was identified.

Manufacturer Narrative

New information received on 03aug2020 after closure of the original complaint investigation indicates the patient had a singleton normal pregnancy confirmed by scan on (b)(6) 2020.Further, the text states that the obstetrician felt that the initial negative b-hcg and subsequent pattern of results are within expectations.Based on the new information and the investigation, alinity i total b-hcg reagent lot 080403ui00 is performing as intended, no systemic issue or deficiency of the reagent 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: 10154932
• MDR Text Key: 226764380
• Report Number: 3005094123-2020-00122
• 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,Followup
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: 07P51-20
• Device Lot Number: 08043UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE,; ALINITY I PROCESSING MODULE,; LIST 03R65-01, SERIAL (B)(6) ; LIST 03R65-01, SERIAL (B)(6) ; LIST 03R65-01, SERIAL (B)(6)