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

Catalog Number 03R89-62

Device Problem High Test Results (2457)

Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  Injury  

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 information will be provided as available.

Event Description

The customer stated that a physician questioned a potassium result for a male patient, sample id (b)(6).The patient was treated for hyperkalemia (calcium gluconate and lasix iv) based on the elevated potassium result of 5.5 mmol/l.The customer noticed that the hemolysis index was high for the sample and was under the impression that the results should have been held for review by the aliniq ams (analyzer management system) instead of auto-verified.The hemolysis rule was checked and was found to have a limit of 250 which means it would hold samples with >250 hemolysis.The sample in question had a hemolysis value of 237 which is below the set limit; therefore, the ams functioned appropriately for the sample according to the rule set.The customer stated that she had previously requested abbott to update the rule with limits per their operating procedures, so she was under the belief that this had been done and the hemolysis index had been updated to hold all samples with hemolysis >125.The following potassium results were provided for the patient: june 8, 2023 at 12:37pm 4.5 mmol/l (normal); june 9, 2023 at 3:29pm 5.5 mmol/l (high, hemolyzed sample); june 9, 2023 at 7:26pm 3.7 mmol/l (normal); june 10, 2023 at 9:10am 3.1 mmol/l (low); june 11, 2023 at 6:10am 2.8 mmol/l (low); june 12, 2023 at 6:40am 3.2 mmol/l (low).Normal range: 3.5 - 5.2 mmol/l the physician had contacted the customer the morning of (b)(6) 2023 requesting a lookback on the sample from (b)(6) at 3:29pm and the customer indicated the sample was hemolyzed.The physician then notified the customer the patient had received treatment based off the result.The patient was discharged 8 days later.

Event Description

The customer stated that a physician questioned a potassium result for a male patient, sample id (b)(6).The patient was treated for hyperkalemia (calcium gluconate and lasix iv) based on the elevated potassium result of 5.5 mmol/l.The customer noticed that the hemolysis index was high for the sample and was under the impression that the results should have been held for review by the aliniq ams (analyzer management system) instead of auto-verified.The hemolysis rule was checked and was found to have a limit of 250.The sample in question had a hemolysis value of 237 which is below the set limit; therefore, the rule was appropriately not applied for the sample.The customer stated that she had requested abbott to update the rule with limits per their operating procedures, so she was under the belief that the hemolysis index had been previously updated to hold all samples with hemolysis >125.The following potassium results were provided for the patient: (b)(6), 2023 at 12:37pm 4.5 mmol/l (normal), (b)(6), 2023 at 3:29pm 5.5 mmol/l (high, hemolyzed sample), (b)(6), 2023 at 7:26pm 3.7 mmol/l (normal), (b)(6), 2023 at 9:10am 3.1 mmol/l (low), (b)(6), 2023 at 6:10am 2.8 mmol/l (low), (b)(6), 2023 at 6:40am 3.2 mmol/l (low).Normal range: 3.5 - 5.2 mmol/l.The physician had contacted the customer the morning of (b)(6), 2023 requesting a lookback on the sample from (b)(6) at 3:29pm and the customer indicated the sample was hemolyzed.The physician then notified the customer the patient had received treatment based off the result.The patient was discharged 8 days later.Additional information was obtained from the customer regarding patient treatment.The only treatment given was calcium gluconate and lasix iv.Twenty minutes after treatment was given, the patient had 5 beats of ventricular tachycardia.The patient was discharged 8 days later.Multiple attempts were made; however, no further details were available regarding presenting symptoms, other clinical findings, correlation between the treatment and ventricular tachycardia, dose given or patient diagnosis.

Manufacturer Narrative

Technical investigations were conducted and confirmed that the aliniq ams worked as expected and the potassium result was evaluated and managed properly per the customer¿s rules.Aliniq ams released correctly to the lis the potassium result for sid (b)(6) as the h-index result (237) was below the set limit and therefore, did not meet the threshold defined in the aliniq ams rule (250) for holding the result.The customer expected to have the specimen result block in aliniq ams due to the elevated h-index (customer's operating procedure states 250 as a decrease effect so to be safe such values should be blocked for clinical evaluations), but the configuration previously agreed with the customer considered a different limit value.To meet the customer's needs and to align the threshold to their operating procedures, h-index limit for potassium was modified and set to 125 so that all potassium results that have h-index >125 should be blocked in aliniq ams.The customer provided the list of updated hil numeric index-limits to be defined for each assay.The aliniq ams rule has been updated accordingly.Trending review determined no trend for the issue for the product.Review did not identify any complaints similar to the issue described in the current complaint.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the available information within the complaint, no malfunctions or deficiencies were identified for the aliniq ams.

• 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: 17283655
• MDR Text Key: 318850400
• Report Number: 3004032053-2023-00018
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Sex: Male