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

Model Number	03R89-48
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased results from aniq ams software for several newborn patients.The ams software has wrong unit of measure 2500 gram entered for apr testing by the abbott field representative (fsr).The apr unit supposed to be in 2.5 kilogram.The abbott field service representative (fsr) entered wrong unit of measure for apr testing.The apr calculation out of those testing c-reactive protein (crp), 1-acid glycoprotein, haptoglobin.The apr calculation is formula derived from c-reactive protein (crp), 1-acid glycoprotein, haptoglobin.The apr calculation used for newborn infection or sepsis.The incorrect apr results reported out of the laboratory, however that formula changed in software by the abbott field service representative (fsr) with correct the unit of measure as 2.5 kilogram.There were no actual results provided for crp, 1-acid glycoprotein, haptoglobin.No further 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
Technical investigations confirmed that the issue was due to a human error performed by the aliniq ams specialist.The issue reported was due to an incorrect configuration of the aliniq ams rule that calculates the apr score: wrong unit of measure (2500) gram entered for hp test where the weight unit is supposed to be in (2.5) kilogram.Therefore, incorrect apr score was calculated and released.To address this scenario configuration change within the aliniq ams rule was performed at the customer site: hp unit of measure for weight has been properly set to (2.5) kilogram.Customer confirmed that 4 incorrect apr results were reported out of the laboratory and sent to the lis.All incorrect results were repeated and correctly released.No impact on neonates¿ health or safety or incorrect medications have been reported.Ticket trending review did not identify any additional complaints similar to the issue described in the current complaint.Device history record review returned no nonconformances or potential nonconformances related to the issue described in the current complaint.A review of the labeling adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the aliniq ams middleware 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: 15581110
• Report Number: 3004032053-2022-00007
• Device Sequence Number: 14998427
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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