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

Catalog Number	03R89-21
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
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 one patients results were incorrectly assigned to another patient by the ams software and reported out of the laboratory.Both patients shared the same sid (b)(4).Results provided: elevated calcium (10.7 mg/dl) and pth (229.1 pg/ml) results from a (b)(6) male patient tested on (b)(6) 2019 were reported on a (b)(6) female patient on (b)(6) 2019 due to the same sid in use by the customer.Due to the incorrect results reported, the female patient from (b)(6) 2019 had an allergic reaction to a radioactive isotope administered during a bone scan.No further information regarding the allergic reaction was provided.A medical opinion was obtained, and a serious injury cannot be ruled out based on the information provided.
Additional Manufacturer Narrative
The complaint investigation indicated that the cause of the elevated calcium and pth results incorrectly assigned to another patient with the same sid was due to a combination of factors.Barcoded sid labels were being reused by the account within a 15-day time frame.Additionally, a parameter in the aliniq ams configuration had been manually disabled by the customers request.By default, this parameter is enabled which prevents patient sample mismatches to be reassigned to a different patient.A review of the product labeling including configuration of order handling concluded that the issue is sufficiently addressed.No adverse trend was identified for the customers issue.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency was identified.

• 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: 8898491
• Report Number: 3004032053-2019-00002
• Device Sequence Number: 13843261
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03R89-21
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR