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

Catalog Number 07P51-20

Device Problem False Positive Result (1227)

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

Event Date 01/06/2020

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 and 7p51-31.Patient identifier does not contain enough spaces, the entire id (b)(6).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 218 miu/ml on (b)(6) 2020 with id (b)(6) ((b)(6)) which did not match the expected result.New samples from (b)(6) 2020 tested negative.The original sample was repeated with a positive result of 80 miu/ml.No impact to patient management was reported.No gender, ethnicity and race was not provided.

Manufacturer Narrative

The ticket search determined normal complaint activity for the lot.Complaint trending report review determined that there is no adverse trend for the product for the current complaint issue.Labelling was reviewed and concluded that the issue is sufficiently addressed.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.A testing protocol was executed using in house retained samples of reagent lot 06112ui00.All validity and acceptance criteria were met during the completion of this protocol, demonstrating that this lot is performing acceptably.No customer returns were available for evaluation.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: 9691281
• MDR Text Key: 220800766
• Report Number: 3005094123-2020-00037
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/21/2020
• 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 Age: 42 YR