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

Catalog Number 07K78-74

Device Problem False Negative Result (1225)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The customer observed false negative architect total b-hcg results for one patient when compared to another method.The architect result was <1.2 iu/ml (reference range 0 to 5 iu/ml), retested <1.2 iu/ml.The customer tested the sample with the gold standard method, and the result was a weak positive.The customer has another new industrial platform that can detect bhcg by chemiluminescence, and this platform has a test result of 0.3 (reference range of 0-10), which is also negative.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Return testing was not performed as returns were not available.Device history record review was performed on lot 31141ud02, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Ticket search by lot indicates that the reagent lot shows normal complaint activity.Labeling review concludes that the issue is adequately addressed.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.The customer confirmed eventually that the result was consistent with the patient¿s clinical presentation.Based on the information within the complaint record, results obtained with the reagent were in alignment with clinical presentation.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Based on all reviewed data, we conclude that there is no product deficiency with the architect total ss-hcg reagent identified in this complaint.Corrected data found in section d3 and g1.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14214681
• MDR Text Key: 290188505
• Report Number: 3005094123-2022-00087
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/14/2022

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: 08/18/2022
• Device Catalogue Number: 07K78-74
• Device Lot Number: 31141UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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, ISR63757.; ARC I2000SR INST, 03M74-02, ISR63757.