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

Model Number	03R89-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported that falsely depressed b12 results were released to the physician for one (b)(6) patient.The physician then changed the b12 dosage based on the depressed result.There was no reported adverse impact to patient management.The customer will not provide any further information.The customer also reported that results were generated correctly on the alinity i analyzer, but interpreted incorrectly by the ams, as the rule was set up wrong by abbott.The flags (< and >) were interpreted as less than the linearity for each assay and were then sent to the lis.The lab technicians then manually reviewed the results and released them to the physicians.The customer stated that 4 patients were potentially impacted by these incorrect results, but information was only provided for the one b12 patient above.The customer also reported falsely depressed cmv, toxo-g, tsh, anti-tpo, anti-thyroglobulin, b12, anti-ccp, folate, (b)(6), progesterone, and vitamin d results.The results provided were: (b)(6).There was no reported impact to patient management.
Additional Manufacturer Narrative
A search of complaints did not identify any complaints similar to the issue described in the current complaint.No trends were identified with the aliniq ams labonline middleware.The investigation performed by the aliniq ams technical group indicated that the issue was due to an incorrectly configured rule within the aliniq ams middleware during implementation.To resolve the issue, the rule was modified to exclude non-numeric results to prevent future occurrences.All results are sent to the lis automatically, however, there was no result validation used in the lab.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the aliniq ams middleware v2.08.Explanation for h.6.Conclusions code 4316 - appropriate term/code not available, the incorrect installation of the software rule by the manufacture.

• Brand Name: ALINIQ AMS
• Common Device Name: ANALYZER MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT S.R.L.; piazza della trivulziana, 4/a; milan 20126 ; IT 20126
• MDR Report Key: 9812613
• Report Number: 3004032053-2020-00002
• Device Sequence Number: 16536093
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03R89-21
• Device Catalogue Number: 03R89-21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1