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

Model Number 03R89-24

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 10/08/2022

Event Type  malfunction  

Event Description

The customer observed after samples were loaded on the alinity i processing module, a request was denied.The technician was on site to troubleshoot the ams connection.While the technician was assisting the removal of the specimen from the alinity i to be placed on the counter, the specimen tube slipped out of their hand.It was reported the serum sprinkled on their arm.The technician was wearing gloves and a mask at the time of the event.While the technician was rinsing and disinfecting their arm, the unclotted wound on their hand was exposed.The sample was tested using the preoperative 8-assay panel.The results were: hepatitis b five-assay panel was positive for 1, 3, and 5 [hbsag, hbeag, and hbcab], and negative for aids, hepatitis c, and syphilis.The technician had blood drawn and was tested using the preoperative 8-assay panel at the laboratory.The hepatitis b five-assay panel was positive for 2 and 5 [hbsab and hbcab], and negative for aids, hepatitis c, and syphilis.No additional information was provided at this time.Additionally, it was reported that the ams communication was normal; however, lis did not send the request to ams.This returned to normal after contacting the lis engineer for troubleshooting.No impact to patient management was reported.

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 patient details are not available.

Manufacturer Narrative

The investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and field data review.A review of the complaint information found the alinity i analyzer did not cause or contribute to the splashing incident as the sample was dropped after it was removed from the analyzer.Labeling was reviewed and sufficiently addresses safety awareness where hazards may exist and biological hazards, which cautions the operator to wear gloves, lab coats, and protective eye wear when handling human sourced material or contaminated system components.A review of historical data was done, and was adequate, with no trends found.A review of the alinity i/architect ia product monitoring review scorecard found no trends with regards to the current issue.Based on the investigation, the exposure was not directly related to either the aliniq ams or alinity i system; the devices met performance specifications and performed as intended, therefore no systemic issue or deficiency was identified.All available patient information was included.Additional patient details are not available.

• 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: 15698098
• MDR Text Key: 307162516
• Report Number: 3004032053-2022-00009
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740145125
• UDI-Public: 00380740145125
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 03R89-24
• Device Catalogue Number: 03R89-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/22/2022
• 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