MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number 7K78-35

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

The customer reported a false negative architect total b-hcg result for a patient.The following data was provided (reference range: /= 25.00 iu/ l is positive): on (b)(6) 2021 = initial result = < 1.2 iu/l.On (b)(6) 2021 = sid (b)(6) (new sample) = 65420 iu/l; sid (b)(6) (retested sample from (b)(6) 2021) result: > 15000.00 iu/l, 1:15 dilution result = 50865.53 iu/l.There was no impact to patient management reported.

Manufacturer Narrative

Patient identifier: sid (b)(6) (samples collected at different times for the same patient).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for a false negative archtitect total b-hcg result included a search for similar complaints, and the review of complaint text, trending data, labeling, field data review and device history records.Return testing was not performed as returns were not available.Complaint activity review by lot indicates that the reagent lot performs as expected for this product.Trending was reviewed and did not identify any trends for the product for the issue.Field data was reviewed and the historical performance in the field of the reagent lot using worldwide data.The median population results for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for lot 25512ud00.The device history record review did not identify any non-conformances or deviations.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect total b-hcg reagent lot 25512ud00 was identified.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12443023
• MDR Text Key: 283586749
• Report Number: 3005094123-2021-00167
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: 7K78-35
• Device Catalogue Number: 07K78-35
• Device Lot Number: 25512UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)