MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT I2000SR ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 03M74-02

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated a false negative (<1.2 iu/l) architect bhcg result on sample id 638205154, that also generated positive (328.31 iu/l) results a minute later when processing on the architect i2000sr analyzer.The account placed the same sample on the same analyzer/track with positive (333.50 iu/l) architect bhcg results.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

The abbott ambassador reviewed the abbottlink logs and observed abnormalities with the lls and pressure monitoring.No additional troubleshooting was performed.A specific cause for the discrepant result was not identified; therefore, the i2000sr analyzer was considered the likely cause.A review of the analyzer service history identified no contributing factors on or around the date of the complaint.There have been no subsequent occurrences of discrepant results.Further review of the customer's instrument logs were reviewed.Multiple level sense errors and sample pipettor movement restricted errors were observed on (b)(6), 2017.A review of the lls log shows an erratic pipettor step pattern for both the r1 and r2 total b-hcg reagent bottles which is suggestive of bubbles or foam in the reagent bottle or a fluidic-related hardware issue.A product labeling review found the architect systems operations manual addresses operational precautions and limitations; specimen handling recommendations and fluidic subsystems troubleshooting.The operations manual also addresses for i system depressed concentration and erratic results.The architect total b-hcg package insert addresses acceptable samples and provides recommendations for sample handling to ensure consistency in results.A review of the architect product monitoring found no similar issues as described in this complaint; no trend associated with the architect i2000sr erratic result rate was identified.Taken together, no systemic issue or deficiency of the architect i2000sr analyzer was identified.

• Brand Name: ARCHITECT I2000SR 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: 6770540
• MDR Text Key: 81962427
• Report Number: 1628664-2017-00305
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K983212
• 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,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03M74-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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 BHCG LIST 07K78-30; LOT 70091UI00