MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG

Model Number 7K78-30

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

No customer returns were available.Investigation of the customer issue included a review of the complaint text, a search for similar complaints and a review of labeling.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Based on the available information, no product deficiency of the architect total bhcg reagent, list number 7k78-30, lot number 70091ui00, was identified.

Event Description

The customer stated that a false negative architect bhcg result of <1.20 miu/ml was generated for a patient sample (id (b)(6)) on (b)(6) 2017.The same sample was retested on the same architect i2000sr analyzer on (b)(6) 2017 and the bhcg result was positive at 32.06 miu/ml.No adverse impact to patient management was reported.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6798554
• MDR Text Key: 82925640
• Report Number: 3005094123-2017-00049
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: (01)00380740014971(17)171114(10)70091UI00
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 70091UI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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