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

Catalog Number 07P51-74

Device Problem False Positive Result (1227)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 7p51-20, that has a similar us product distributed in the us, list 7p51-21, 7p51-31.An evaluation is in process.A follow up report will be submitted when the evaluation is completed.

Event Description

The account generated false positive alinity i total b-hcg of 791.56 iu/l with sid (b)(6) on (b)(6) 2020 that repeated alinity i negative and architect negative.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

Section a.Patient information added for age, sex, race, ethnicity.Section d.4 catalog updated from 07p51-20 to 07p51-74.Lot updated from 12122ui00 to 12122ui01 the complaint evaluation for a false positive result when tested with the alinity i total b-hcg assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review and in-house testing of the complaint lot.Trending review determined no adverse trend for the product.The ticket search determined normal complaint activity for the lot.This ticket is the only complaint for this lot number and complaint issue.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Labelling was reviewed and addresses the complaint issue adequately.A testing protocol was executed using in house retained samples.All validity and acceptance criteria were met during the completion of this protocol, demonstrating that the lot is performing acceptably.A review of the product quality history for the lot number using search of the corrective and preventative actions system did not identify issues associated with the customers observation.Based on the evaluation, there is no general issue with the alinity i total b-hcg reagent lot identified in this complaint.No product deficiency 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: 10160889
• MDR Text Key: 220961994
• Report Number: 3005094123-2020-00125
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Catalogue Number: 07P51-74
• Device Lot Number: 12122UI01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE; LIST 03R65-01, SERIAL (B)(4); LIST 03R65-01, SERIAL (B)(4)
• Patient Age: 30 YR