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

Catalog Number 01L86-01

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation of the customer issue included a review of the complaint data, troubleshooting by abbott field service, a review of service history, a search for similar complaints, and a review of labeling.Return material was not available.An abbott field service engineer (fse) completed troubleshooting of the instrument.This involved a shutdown of the analyzer the cmia optics board; the optics background check passed upon repeat.A review of the analyzer service history was performed and no contributing factor to the current event was found.There have been no subsequent contacts from the customer regarding discrepant results since the fse reset the cmia optics board.Tracking and trending did not identify an adverse.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect i1000sr analyzer, list number 01l86, was identified.

Event Description

The customer generated a (b)(6) b-hcg result while using the architect i2000sr analyzer.The customer indicated the initial result was (b)(6) (<1.2) and the retest result was (b)(6) (result not provided) for a known pregnant patient.There was no impact to patient management reported.

• 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: 6557473
• MDR Text Key: 74917678
• Report Number: 1628664-2017-00203
• Device Sequence Number: 0
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• 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: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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; LN 07K78-26, LOT 58827UI00