MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP SAMPLE ACCESS LINE (SAL) ALINITY CI-SERIES MODULE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q28-01

Device Problem Unable to Obtain Readings (1516)

Patient Problem Cardiac Enzyme Elevation (1838)

Event Date 10/14/2023

Event Type  Death  

Event Description

Abbott laboratories has been notified of a patient death.The following details about the incident were provided by the customer.The customer stated that there was a delayed alinity c creatine kinase result for a 73 year old male patient in the emergency department (ed) on (b)(6) 2023.(b)(6) 2023 20:00 pm.The patient presented to the ed, conscious and not tachypneic.Capillary refill time (crt) <2 seconds.Pulse rate 127 beats per minute.Blood pressure 200/121.The patient was given iv lasix 40 mg which lowered blood pressure to 112/81.Ekg/ecg was performed.The patient was given iv hydrocortisone 200 mg.21:26 pm laboratory staff received a sample tube from the patient (sid (b)(6)) for creatine kinase (ck) testing.The laboratory staff placed the tube into the sample access line (sal) alinity ci-series component of the glp systems track for testing on the alinity c processing module.21:41 pm error 28114, analysis failed, was detected.(b)(6) 2023 00:22 am.Laboratory staff received a phone call from the ed asking for the patient result.The laboratory staff checked their lis and ams, but no result was found.They checked the input/output module (iom) for the glp systems track and could not find the sample in the output area due to glp error 22600, potential contamination happened on (b)(6) 2023 at 21:43.The laboratory staff rejected the sample tube as hemolyzed due to the error message and requested a new sample from the ed.02:54 am laboratory staff retrieved the sample tube successfully from the iom and proceeded to manually front load the sample tube directly onto the alinity c processing module, serial number (b)(6), for testing.03:39 am the alinity c generated a creatine kinase result of 687 u/l.However, the laboratory staff did not release the result to the ed due to the previous sample tube rejection.04:00 am the patient was given iv lasix 40 mg.06:39 am the laboratory staff received the new sample from the patient, sid (b)(6), and front load the sample tube directly onto the alinity c processing module, serial number (b)(6), for testing.07:27 am the creatine kinase result of 1287 u/l was reported.(b)(6) 2023 02:15 am.The patient passed away.The cause of death listed in the patient's discharge note was decompensated chronic cardiac failure (ccf) precipitated by acute coronary syndrome (acs).No further information about the patient or the incident has been provided.

Manufacturer Narrative

This report is being filed on an international product, list number 06q28, that has a similar product distributed in the us, list number 04z96.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 Description

Abbott laboratories has been notified of a patient death.The following details about the incident were provided by the customer.The customer stated that there was a delayed alinity c creatine kinase result for a 73 year old male patient in the emergency department (ed) on (b)(6), 2023.On (b)(6), 2023, 20:00 pm.The patient presented to the ed, conscious and not tachypneic.Capillary refill time (crt) <2 seconds.Pulse rate 127 beats per minute.Blood pressure 200/121.The patient was given iv lasix 40 mg which lowered blood pressure to 112/81.Ekg/ecg was performed.The patient was given iv hydrocortisone 200 mg.21:26 pm, laboratory staff received a sample tube from the patient (sid (b)(6)) for creatine kinase (ck) testing.The laboratory staff placed the tube into the sample access line (sal) alinity ci-series component of the glp systems track for testing on the alinity c processing module.21:41 pm, error 28114, analysis failed, was detected.On (b)(6), 2023, 00:22 am, laboratory staff received a phone call from the ed asking for the patient result.The laboratory staff checked their lis and ams, but no result was found.They checked the input/output module (iom) for the glp systems track and could not find the sample in the output area due to glp error 22600, potential contamination happened on (b)(6), 2023 at 21:43.The laboratory staff rejected the sample tube as hemolyzed due to the error message and requested a new sample from the ed.02:54 am, laboratory staff retrieved the sample tube successfully from the iom and proceeded to manually front load the sample tube directly onto the alinity c processing module, serial number (b)(6), for testing.03:39 am, the alinity c generated a creatine kinase result of 687 u/l.However, the laboratory staff did not release the result to the ed due to the previous sample tube rejection.04:00 am, the patient was given iv lasix 40 mg.06:39 am, the laboratory staff received the new sample from the patient, sid (b)(6), and front load the sample tube directly onto the alinity c processing module, serial number (b)(6), for testing.07:27 am, the creatine kinase result of 1287 u/l was reported.On (b)(6), 2023, 02:15 am, the patient passed away.The cause of death listed in the patient's discharge note was decompensated chronic cardiac failure (ccf) precipitated by acute coronary syndrome (acs).No further information about the patient or the incident has been provided.

Manufacturer Narrative

Section h6, component code was updated from g03001 to g02008.During the investigation, it was identified that the incident that occurred on (b)(6) 2023 could have been potentially impacted by a known issue with the glp sal alnty-ci bsc kt, list number 06q28-01.While processing tests from a sample tube in a car clamped in the accesspoint of the sal alinity ci, the issue can cause the car to be prematurely released while the alinity continues processing that sample.If an incoming car is read at the accesspoint during the processing of the previous sample, then error 22600: potential contamination (sample handling) will be generated.This issue may lead to cross contamination from the sample of the car that was released with the sample in an incoming car, sample aspiration from an incoming car where the results are associated on the alinity ci-series with the car that was released or cause a collision between the sample probe and a sample tube in a car.This incident occurred while the sal alinity ci module was on software version 1.3.0.A review of tickets did not identify any trends related to the current issue for the glp sal.A cross functional team (cft) consisting of medical affairs, technical operations, and product quality reviewed the complaint information and determined the adverse event was related to use error as the customer received the fa15sep2022 product correction letter but did not perform the necessary actions to mitigate the issue.The customer confirmed receipt of the product correction letter on 27oct2022.Review of the operations manual shows that the sample access line abbott alinity ci-series provides causes and corrective action for error code 22600.A review of the glp systems track risk analysis was performed by technical operations.The relevant sequence of events and modes of control for delayed results have already been addressed, therefore no updates to the risk management file are required.The root cause was determined to be attributed to the design of the software due to releasing the car after a car id read failure at the accesspoint and sending no specimen immobilization errors to the analyzer.The issue was addressed in glp sal alinity ci software v 1.3.4., which the affected customer has since been upgraded to as of 30oct2023.This new software does not automatically release cars when the a car id fails to read and instead it waits until the aspiration cancellation process has been confirmed as finished by the analyzer.Additionally, the update reports specimen immobilization errors to the analyzer such that all associated tests are sent to exception.Unique sid-error codes (28128: questionable analysis result and 28130: potential cross-contamination of sample) are generated for better error handling at track workflow manager (twm) and track sample manager (tsm), allowing for more mitigations/rules to be implemented at the middleware level.Based on the investigation, a deficiency was identified with the glp sal alinity basic kit, list number 06q28-01; as the device did not meet performance specification per the operations manual glp systems track laboratory automation system sal abbott alinity ci-series sample access line abbott alinity ci-series.This report is being filed on an international product, glp sal alinity ci basic kit, list number 06q28-01, which has a same/similar component of the modular glp system track approved in the us, list number 04z96-51.Note: the glp systems track is in process to be commercialized in the us.The sal alinity ci software in the glp sal alinity ci basic kit distributed in the us will contain the design updates previously described in this write-up; therefore, the potential for this issue to occur on glp systems track installations in the us will not exist.

• Brand Name: GLP SAMPLE ACCESS LINE (SAL) ALINITY CI-SERIES MODULE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18094885
• MDR Text Key: 327663831
• Report Number: 3023268435-2023-00038
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K213486
• 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,Followup
• Report Date: 01/11/2024

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 Catalogue Number: 06Q28-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/11/2024
• 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
• Treatment: ALNTY C CREATINE KINASE, 08P42-20, 14743UN23; ALNTY C CREATINE KINASE, 08P42-20, 14743UN23; GLP TRACK END, 06Q42-01, AAS154; GLP TRACK END, 06Q42-01, AAS154
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Male