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

Catalog Number 07K78-25

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 05/31/2014

Event Type  malfunction  

Event Description

The customer stated that one patient sample generated discrepant results for the architect b-hcg assay.A negative result was repeated positive on another instrument in the lab.The positive result aligned with the patient ultrasound.No impact to patient management was reported.

Manufacturer Narrative

(b)(4).Product evaluation is in process and the results will be submitted in a follow-up report.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from the architect bhcg reagent, list number 07k78-25, with (b)(4) as the manufacturing site of this report to the architect i2000 instrument, list number 03m74-01, and(b)(4) as the manufacturing site of the new suspect device.Mdr number 1628664-2014-00220 has been submitted and all further information is documented under that mdr number.

• 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: 3902961
• MDR Text Key: 4649287
• Report Number: 3005094123-2014-00018
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2014

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 Catalogue Number: 07K78-25
• Device Lot Number: 36901UI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 06/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT ANALYZER I2K 03M74-01 SN (B)(4)