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

Catalog Number 07K78-77

Device Problem False Negative Result (1225)

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

Event Date 07/03/2021

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 3016438761-2021-00266 under a different suspect medical device.The suspect medical device was changed on (b)(6) 2021 upon further investigation of the customer issue.Historical quality metrics review determined normal complaint activity for the lot.Complaint trending report review determined that there is no related non-statistical or adverse trend for the product.Labelling review concluded that the issue is adequately addressed.Historical performance in the field of the reagent lot using worldwide data through abbottlink was evaluated.The median population result for the lot is within established baselines and comparable with all other lots in the field and confirms no systemic issue for this lot.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.The test results generated were caused by incorrect formulation of the wash buffer.

Event Description

The customer reported false negative architect b-hcg results on one patient.The results provided were: initial = 3.8miu/ml (<5.00miu/ml = negative); about 3 pm on a different module the result = 387miu/ml(>/=25.00miu/ml = positive).The controls were within range in the morning and the negative result was generated at noon.There was no reported impact to patient management.

• 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: 12555757
• MDR Text Key: 274079787
• Report Number: 3005094123-2021-00187
• 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
• Report Date: 09/30/2021

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: 08/06/2021
• Device Catalogue Number: 07K78-77
• Device Lot Number: 19561UI01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR55825