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

Catalog Number 07K78-30

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative b-hcg result on the architect i2000sr analyzer.The following data was provided (miu/ml): (b)(6): initial 1.57, repeats 27.43, 25.03, initial 36.03, repeat 33.75.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data and accuracy testing.This review showed increased complaint activity for product lot 81083ui00 related to false positive patient results.There was no increase in complaint activity for false depressed patient results, and no adverse trend was identified.Labeling was reviewed and found to be adequate.The product was not available for return.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits and there is no systemic issue for this lot.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• 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
• MDR Report Key: 7716759
• MDR Text Key: 114946094
• Report Number: 3005094123-2018-00025
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• 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: 10/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2018
• Device Catalogue Number: 07K78-30
• Device Lot Number: 81083UI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(4); LN 03M74-02 SN (B)(4)