MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I1000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 01L86-01

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed false negative beta human chorionic gonadotropin (b-hcg) results for one patient while using architect i1000sr analyzer.The following results were provided (miu/ml).Initial less than 1.2 (negative).Previous result was 100 (positive), and was tested 2 days prior to the low result.No impact to patient management was reported.

Manufacturer Narrative

Field service was dispatched after the customer observed leaking at the trigger/pre trigger valves.Service replaced the valve and the manifold kit and the system functioned as intended.The valve, manifold kit was considered the likely cause of the issue.A review of i1sr51252 service history identified no contributing factors on or around the date of the complaint, and there have been no subsequent contacts from the customer regarding error codes/erratic/discrepant results since the valve, manifold kit was replaced.A review of labeling concluded that the issue is sufficiently addressed.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.A malfunction was identified.Based on the information within the complaint record, the device failed to meet performance specifications or otherwise perform as intended at the customer site.No product deficiency or systemic issue was identified.

• Brand Name: ARCHITECT I1000SR ANALYZER
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• 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: 6466428
• MDR Text Key: 72206621
• Report Number: 1628664-2017-00097
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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: ARCHITECT TOTAL B-HCG REAGENT; LIST NUMBER 07K78-25; LOT NUMBER UNKNOWN