MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The field service engineer (fse) was servicing an alinity s system on 14 sep 2023.The fse was cut on the left hand by a wash zone probe.The fse was wearing a pair of gloves at the time of the event.The cut minor and the fse washed and applied alcohol to the area.The fse went to the emergency department, where blood work was taken, and a tetanus shot was administered.On 15 sep 2023, fse return to hospital for an hb titer (to check for immunity) in addition to an hiv prophylaxis prescription.The titer was performed and fse was provided a prescription for biktarvy 50-200-25mg.Prescription was filled and fse took his first pill around 6:30p on 15 sep 2023.Fse was advised that side effects of the prescription is liver/kidney damage and that additional blood work is needed to monitor those organs.The cut minor and the area was washed and applied alcohol.Blood work was taken, a tetanus shot was administered, and an hiv prophylaxis was prescribed.Additional blood work is required for monitoring.Additional labs were drawn for a comprehensive metabolic panel and urine analysis.Hiv test is planned to be repeated in 6 months.
Additional Manufacturer Narrative
The alinity s system, serial number (sn) (b)(6) was inspected as part of the preventative maintenance and wash zone 1 of process path 2 required reinstallation in which the field service fse was scratched on the back of the hand by a wash zone probe.Return testing was not completed as returns were not available.The instrument service history review revealed no additional occurrences related to probe injuries.A review of tracking and trending did not identify any trends for the wash zone probe and review found no similar issues related to the reported issue.A review of the manufacturing documentation did not identify any deviations, non-conformances, or potential non-conformances related to a wash zone probe.A review of the alinity s system documentation determined documentation addresses probe and other sharp hazards and precautions on contaminated instrument components.Based on the available information, no systemic issue or deficiency of the alinity s system, serial number (sn) (b)(6) or wash zone probe was identified.The following sections have been corrected: g1-contact office first name.G1-contact office last name.G1-contact office address 1.G1-contact office city.G1-contact office zip code.G1-contact office country.G1-contact office phone number.G1-contact office email.G1-contact office fax number.
Event or Problem Description
The field service engineer (fse) was servicing an alinity s system on (b)(6) 2023.The fse was cut on the left hand by a wash zone probe.The fse was wearing a pair of gloves at the time of the event.The cut minor and the fse washed and applied alcohol to the area.The fse went to the emergency department, where blood work was taken, and a tetanus shot was administered.On (b)(6) 23, fse return to hospital for an hb titer (to check for immunity) in addition to an hiv prophylaxis prescription.The titer was performed and fse was provided a prescription for biktarvy 50-200-25mg.Prescription was filled and fse took his first pill around 6:30p on (b)(6) 23.Fse was advised that side effects of the prescription is liver/kidney damage and that additional blood work is needed to monitor those organs.The cut minor and the area was washed and applied alcohol.Blood work was taken, a tetanus shot was administered, and an hiv prophylaxis was prescribed.Additional blood work is required for monitoring.Additional labs were drawn for a comprehensive metabolic panel and urine analysis.Hiv test is planned to be repeated in 6 months.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17844623
• Report Number: 1628664-2023-00010
• Device Sequence Number: 7182570
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown