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

Model Number	03R89-47
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated falsely decreased hemoglobin and mchc results were released by the aliniq ams base software.The customer stated the results were generated on the alinity hq analyzer and were flagged with an ¿x¿ which indicated that the results were invalided.The aliniq ams released the results, and the results were reported to the physicians.The customer has corrected the hemoglobin results.The customer stated some of the patients had to have a new blood draw.The customer is using the optical hemoglobin (chgb) as the correct values.The following data was provided: hemoglobin reference ranges: 0-8 days: 8.5 to 12.5 mmol/l; 8 days-6 years: 6.0 to 9.0 mmol/l; 7 years-15 years: 6.5 to 10.0 mmol/l; male >15 years: 8.5 to 11.0 mmol/l; female >15 years: 7.5 to 10.0 mmol/l.Mchc reference range = 19.0 to 23.0 mmol/l.All the following results were generated on (b)(6) 2023.(b)(6).Sid (b)(6) mchc = 15.2 mmol/l; hgb = 7.05 mmol/l; hgb corrected to = 9.45 mmol/l.For this sample, the sample report showed all results flagged with an ¿x¿ which invalidated the results.Hgb interference flag also present.Other system messages were mchc out of range; check sample integrity; nrbc boundary not found.Sid (b)(6) mchc = 18.0 mmol/l; hgb = 6.61 mmol/l; hgb corrected to = 7.56 mmol/l.For this sample, the sample report showed hgb interference flag.Sid (b)(6) mchc = 13.9 mmol/l; hgb = 5.07 mmol/l; hgb corrected to = 7.86 mmol/l.For this sample, the sample report showed all results flagged with an ¿x¿ which invalidated the results.Hgb interference flag and left shift flag also present.Other system messages were mchc out of range and check sample integrity.No impact to patient management was reported.
Additional Manufacturer Narrative
Describe event or problem: updated with additional information provided on 09mar2023.
Event or Problem Description
On 09mar2023, additional information was provided by the customer.It was noted that there was no configuration setup in the aliniq ams base software to hold the invalidated results flagged with an "x".
Additional Manufacturer Narrative
Technical investigations performed by the abbott specialist revealed that there was no setup intended to hold the invalid results flagged with a "x".Special characters (such as the ¿x¿ flags or ¿*¿ within a result received from the instruments) are managed through an aliniq ams custom rule in the onreceiveresult event that was requested and agreed with the customer.Final test results are assessed by the actual result in combination with the send result-flags and sample-flags from the alinity hq.When a specific character is received from the alinity hq analyzer and detected, the rule removes it replacing the final result with the numeric part and adds a qpl info with ¿alarm¿.Aliniq ams events review confirmed that the rule triggered and worked as expected and samples were managed accordingly with the configuration and workflow requested by the customer.The root cause of the event was a false expectation by the customer about the hematology test valued with a ¿x¿ in the instrument result.The customer expected a block of the results with ¿x¿ for manual validation by the laboratory technician, but the configuration previously agreed with the customer did not consider the block.To meet the customer¿s expectation of having all the results with ¿x¿ blocked by aliniq ams for manual actions by the laboratory, it was proposed to implement new rules intended to manage data flags for hematology.The customer confirmed that they preferred to maintain the current configuration.Since the customer did not accept the new proposed implementation, no actions have been taken in the aliniq ams middleware.Ticket trending was reviewed and identified no additional complaints similar to the issue described in the current complaint.The device history record was reviewed and did not identify any non-conformances or potential non-conformances related to the issue described in the current complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, the aliniq ams middleware is performing as intended, no systemic issue or deficiency of the aliniq ams middleware was identified.
Event or Problem Description
On 09mar2023, additional information was provided by the customer.It was noted that there was no configuration setup in the aliniq ams base software to hold the invalidated results flagged with an "x".

• Brand Name: ALINIQ AMS
• Common Device Name: 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: 16427404
• Report Number: 3004032053-2023-00007
• Device Sequence Number: 11418517
• Product Code: JQP
• UDI-Device Identifier: 00380740189907
• UDI-Public: 00380740189907
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03R89-47
• Device Catalogue Number: 03R89-47
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 04/21/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/30/2023; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown