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

Catalog Number	03R89-63
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed hil interpretation was not updated after rerun not hemolyzed specimen from alinity c processing module which connected to alniq ams software.The customer did not centrifuge the patient specimen and ran whole blood (hemolyzed) on alinity c processing module.The specimen was not centrifuge so provided >500 with text grossly hemolyzed.According to ams software rule grossly hemolyzed specimen should hold for rerun that rule worked and held specimen for rerun.The customer centrifuged and rerun that specimen.The specimen was not hemolyzed after centrifuged and got < 10.The ams supposed to change text to from > 500 grossly hemolyzed to < 10 with not hemolyzed.The ams software reported < 10 with incorrect grossly hemolyzed text to lis.The interpretation does not match with specimen condition.The customer expected that if <10 should change text to not hemolyzed.The ams software did not perform the way supposed to for interpretation on not hemolyzed specimen.The abbott fsr changed the rule in ams software.The lis setting changed due to ams software rule changed.The customer corrected the not hemolyzed text with patient results.No other discrepant patient results provided by the customer.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The abbott specialist performed technical investigations, revealed that the issue was the error from the laboratory operator who did not centrifuge the samples before processing them.Since the date the site went live to the date of the issue (more than one year and half), all samples prepared according to the requirements (i.E., centrifuged) have been correctly processed by the rule.Nevertheless, the technical investigation also identified as contributing cause the misinterpretation of the rule behavior by the its, not considering the special case of lack of sample centrifugation with consequent rerun.A hil tests rerun is an unusual practice because reruns in the great majority of cases provide the results consistent with those of the first run; the issue was resolved on 31-jul-23 on site: based on the modified middleware configuration, when hem rerun result is below the threshold (30), the expected value ¿not hemolyzed¿ is properly assigned in aliniq ams to the corresponding hem-i result.A review of tracking and trending of the aliniq found no additional complaints replated to the complaint issue.Therefore, no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Based on the investigation the aliniq ams is performing as intended, no systemic issue or deficiency of the aliniq ams was identified.

• 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: 17604553
• Report Number: 3004032053-2023-00022
• Device Sequence Number: 6263214
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: 00380740202736
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 11/14/2023

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 Catalogue Number: 03R89-63
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown