MAUDE Adverse Event Report: ABBOTT SRL ALINIQ AMS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 03R89-48

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

A review of 12-months of complaints identified no additional similar complaints for the aliniiq ams.A review of the nonconformances within the abbott diagnostics quality management system did not identify any issues associated with the aliniq ams product for the complaint issue.Product labeling was reviewed and found to address the customer¿s issue: configurator, user manual, rev.: 0 - product suite: 2.12 and aliniq ams, user manual, rev.: 0 - product suite: 2.12 provides adequate information on how to configure and/or enable and disable test channel association.No return analysis was performed as the aliniq ams remains in use at the customer site without further issue since reported by the laboratory concerned.A review of service history for the alinity i processing module, serial number (b)(4) identified no subsequent tickets were documented for delays in processing patient samples and no contributing factors on or around the date of the incident were identified.A review of 12-months of complaints identified no additional complaints of delayed results for the alinity i processing module.Review of tracking and trending for alinity i/architect ia pmr (product monitoring review) scorecard did not identify any trends for either complaints involving the analyzer or delay in results.A review of the nonconformances within the abbott diagnostics quality management system did not identify any issues associated with the alinity i instrument or the complaint issue.Labeling was reviewed.The alinity ci-series operations manual addresses use of system logs for troubleshooting.The environmental troubleshooting variables relate to the processing of results and includes host interface components.No return analysis was performed as the alinity i processing module remains in use at the customer site.To further investigate the issue, a review of the customer¿s site configuration and available system logs was conducted.This review included analysis from log files across multiple abbott diagnostics product lines including the aliniq ams system, multiple serial numbers of alinity i analyzers at the customer¿s site as well as the customer¿s aas glp automation track system.During this review, it was determined that the sample for cortisol testing was manually loaded onto the analyzer via the rsm (reagent and sample manager) by the operator.Manual operation excludes influence from the customer¿s aas glp track system (i.E.The track was not used to deliver the sample to the analyzer).Further, the review identified that the customer¿s analyzers (serial numbers (b)(4)) did not have a cortisol test ordered for sample (b)(6) on (b)(6) 2021.With this information, it was concluded that the root cause for the issue was use error.The laboratory staff potentially performed an excursion of standard manual management of the sample.Manual use of sample handling in conjunction with the use of the aliniq ams system must be carefully managed by the laboratory staff to make sure that a sample is placed on all necessary analyzers in a timely manner.In this incident, the laboratory staff manually loaded the sample on an instrument where the cortisol test was disabled and only the following day of the event the patient sample was detected as incomplete.It was then loaded on an analyzer (alinity ci module) where the sample was processed since the cortisol test was enabled.The correct test result was provided in a timely manner by the aliniq ams.Based on the investigation performed, the aliniq ams system list number 03r89-48 is performing as intended; no systemic issue or deficiency was identified.Additionally, the investigation concluded that the alinity ci systems and the glp automation track systems also performed as intended at the customer site and no systemic issues or product deficiencies were identified.

Event Description

Abbott has been notified of a patient death on (b)(6) 2022.The customer reported treatment was not provided to a patient as a result of a delay in generating alinity i cortisol results while using the alinity i processing module.Review of the event identified that there was an approximately 30-hour timeframe between when the sample was introduced to the track system and the analyzer providing results to the customer [request received (b)(6) 2021 at 08:58.Cortisol result returned on (b)(6) 2021 at 14:25 (30 hours 27 minutes)].The customer stated the clinical team did not treat the patient with hydrocortisone medication in a timely manner as they were not aware of the low cortisol status.The sample returned a cortisol result of <27.6 [linear range of the assay is 27.6 to 1649.9 nmol/l].The patient was tested for cortisol on the day prior ((b)(6)2021 09:30 am) with result 132.The customer does not question the cortisol results generated.The patient was a 78-year-old male who reported headache and vomiting.The (b)(6) was provided.The following results were generated: sodium 144, potassium 3.4 low, urea 7.8, creatinine 142 high, crp 55 high, cortisol <28 low, prolactin 102, testosterone 5.0 high, tsh 1.7, free thyroxine 13.3, free t3 4.0, hemoglobin 141, wcc 8.93, platelet 196, rcc 4.72, hematocrit 93.4, mcv 93.4, mch 29.9, mcrc 320, rcw 14.2, neutrophils 5.97, lymphocytes 1.83, monocytes 0.83, eosinophils 0.22, basophils 0.08, nucleated rbc 0.00.The patient expired.No further information was provided by the customer for details surrounding the patient death (eg date of patient death, clinical diagnosis while being treated in hospital, coroner's report details, etc).The customer has advised that they intended to report the incident to the competent authority and provided the following number: 2022/002/004/401/005.The report was subsequently provided by the local competent authority and reviewed.Review did not identify any additional information regarding the patient or circumstances surrounding the event, however the customer reported in this report that ams/alinity driver repaired by abbott on the (b)(6) 2021 and communication problems resolved.

• Brand Name: ALINIQ AMS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer (Section G): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14192526
• MDR Text Key: 299168948
• Report Number: 3004032053-2022-00003
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 04/25/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Male