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 01/04/2020

Event Type  malfunction  

Manufacturer Narrative

Complete information for patient identifier = sid= (b)(6).There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.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 a false positive alinity i b-hcg results on one (b)(6) year old female patient.On (b)(6) 2020 the patient arrived at the emergency room with abdominal pain.The initial b-hcg results were: (b)(6) 2020 sid (b)(6) = 36.16iu/l (>/=25.00 iu/l = positive).The hospital did not have a gynecologist on site at that time and the patient was not able to be treated for the pain due to the positive b-hcg result.On (b)(6) 2020 the patient had an echograph of the abdomen showing an inflamed appendix.The patient underwent immediate surgery.A new sample was drawn on (b)(6) 2020 = negative / a retest of the (b)(6) 2020 serum sample = <2.30iu/ l (

Manufacturer Narrative

A review of tickets determined normal complaint activity for lot 04527ui00, and no trends were identified for the product.Return testing was not completed as returns were not available.Historical performance of reagent lot 04527ui00 was evaluated using world wide data from abbottlink.The data determined that the patient median result for the lot is comparable to other lots in the field and confirms no systemic issue.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 04527ui00.

• 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: 9632848
• MDR Text Key: 221030531
• Report Number: 3005094123-2020-00024
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: 07P51-20
• Device Lot Number: 04527UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• 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)
• Patient Age: 19 YR