MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ALINIQ AMS; ANALYZER MANAGEMENT SYSTEM

Catalog Number 03R89-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed an falsely elevated potassium result (6.3) on the aliniq ams software.The female patient sid (b)(6) (born (b)(6)) received an unnecessary administration of the following: 10 units actrapid insulin and 50ml 50% dextrose iv, 100ml 10% calcium gluconate iv.The customer states the patient was since discharged and a long-term negative impact is not anticipated.

Manufacturer Narrative

On july 1, 2019 the suspect medical device was corrected from 03r89-21 (ams version 2.08) to 03r89-01 (ams version 2.06).The ams product software version 2.06 does not have a same/similar product on market in the usa, therefore this event is no longer reportable in the usa.The serial number of the concomitant product was added.Clarification of event: the laboratory staff identified the incorrect result after the clinical team made a request to perform a liver function test on this sample.The incorrect result was then alerted to the clinical team and the result withdrawn.Upon obtaining the high result, the customer did not repeat testing to confirm the result.A product evaluation was performed.The lipemia result for the patient sample was 3.07 g/l, and was marked as lipemic by the ams middleware due to the lower paracetamol assay tolerance to lipemia, which is set at less than 2 g/l.The ams middleware had remarked the patient sample with the qpl rule suggestion of lipemia found which would have alerted the customer that further sample processing is needed to address the presence of lipemia and also blocks the hemolysis flag from initially being generated until the lipemia is addressed and the lipemia test is repeated.In addition, all tests results affected by the lipemia result were locked by the ams middleware and not intended to be released (unblocked) until the lipemia test was reran.The patient sample was not treated as lipemic by the customer as directed in the laboratory's lipemic sample protocol, and the patient sample was not retested.The customer manually unblocked, validated and released the falsely elevated potassium result without generation of a hemolysis flag by ams, as the ams middleware was awaiting a rerun of the lipemic sample before triggering the hemolysis flag.The laboratory's standard operating procedure (sop) regarding pre-analytical and analytical interferences for lipemia states the following: for high levels of lipemia, an off-board centrifugation process must be applied to remove the lipid content.The customer failed to identify and appropriately respond to an elevated hemolysis result, which was available for them to review along with all the other test results for this sample, prior to result release from the laboratory.This was highlighted to the customer to mitigate potential future related events.No adverse trend was identified for the customer's issue.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ALINIQ AMS
• Type of Device: ANALYZER MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8718254
• MDR Text Key: 148656613
• Report Number: 1628664-2019-00451
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000; SERIAL NUMBER (B)(4).
• Patient Outcome(s): Other
• Patient Age: 40 YR