MAUDE Adverse Event Report: ABBOTT S.R.L. ALINIQ AMS; ANALYZER MANAGEMENT SYSTEM

Catalog Number 03R89-20

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

This report was previously submitted under an incorrect manufacturing location in 1628664-2019-00395.The complaint text stated that troponin results were being reported as <2 due to a previous rule update in the aliniq ams middleware.While defining a closed interval range for results between 0-2, the previous rule caused all the results in that range (0-2) to be reported as <2.It was discovered that the rule was incorrectly configured by an abbott representative to use a boolean operator of "or" instead of "and".This caused all results greater than 0.1 to be reported as <2 even if the results were >or=2.The issue was resolved by correctly configuring the "and" boolean operator to define the correct range, which will report results of <2 for values between 0-2.Historical quality metrics were reviewed, and no adverse trend was identified for the customer's issue.No additional complaints similar to the customer's issue were identified.Labeling was reviewed.The smart rule editor (s.R.E) user manual revision 5.01.1+ provides labeling information on configuring templates for rules.The abbott representative inadvertently configured the rule incorrectly.Based on the available information, no product deficiency was identified.

Event Description

The customer stated that all alinity i stat high sensitive troponin-i results were reported as <2 pg/ml following an update to the aliniq ams (analyzer management system) quantitative result rule configuration on april 10, 2019.A total of 320 alinity i stat high sensitive troponin-i results were reported incorrectly for alinity i serial numbers: (b)(4) during the timeframe of (b)(6) 2019.Of that total, 148 results were above a cutoff of >16 pg/ml and 106 results were above a cutoff of >30 pg/ml.The alinity i processing modules generated correct stat high sensitive troponin-i results, but the aliniq ams was inappropriately configured to change the results to <2 pg/ml.The customer had requested a change to the rule, but logic for the rule was overlooked and the rule was activated.The rule did not get validated by the customer prior to implementation.The rule was reconfigured to report alinity i stat high sensitive troponin-i results correctly on (b)(6) 2019.None of the <2 pg/ml results were questioned by a medical practitioner.The clinical significance of the incorrectly reported results was determined by the customer and actions to recall patients was assessed on a case-by-case basis.All results were reviewed and corrected by the biochemistry staff.Five patients were called back for further review.Unnecessary additional blood draws were performed with no resulting patient harm.Discharge summaries were reviewed by the customer and patients appear to have been managed appropriately.There was no negative impact or harm reported for any of the patients.The customer stated that 8 of the patient are deceased, but the patients died due to reasons/conditions not related to the alinity i stat high sensitive troponin-i results.The customer confirmed that the results did not cause, or contribute to the patient deaths and that the patient outcomes of death would have been the same for these patients even if the correct alinity i stat high sensitive troponin-i results had been reported.

• Brand Name: ALINIQ AMS
• Type of Device: ANALYZER MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT S.R.L.; piazza della trivulziana, 4/a; milan 20126 ; IT 20126
• Manufacturer (Section G): ABBOTT S.R.L.; piazza della trivulziana, 4/a; milan 20126 ; IT 20126
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 8888540
• MDR Text Key: 219506426
• Report Number: 3004032053-2019-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1