MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Catalog Number 08P07-32

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

A customer was splashed in the eye with alinity i hiv combo calibrator.The customer was not wearing protective glasses.No treatment was received.No further data available.No impact to patient management was reported.

Manufacturer Narrative

The customer was splashed in the eye when using the alinity i hiv ag/ab combo calibrator.The customer did not wear protective eyewear at the time of the incident.Trending review did not identify any trends for the issue for the product.An instrument service history review revealed no contributing factors on or around the date of the complaint.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did not identify any trends for the issue for the product.The alinity ci-series operations manual addresses operator responsibility, biological safety hazards and chemical safety hazards that include wearing personal protective equipment (ppe) and safety awareness where hazards may exist.A labeling was reviewed and found to be adequate.No reagent malfunction was identified.Based on the information within the complaint record a use error may have contributed to the exposure described in this complaint as protective eyewear was not worn while handling human sourced materials.

Event Description

A customer was splashed in the eye with alinity i hiv combo calibrator.The customer was not wearing protective glasses.No treatment was received.No further data available.No impact to patient management was reported.

• Brand Name: ALINITY I HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18445698
• MDR Text Key: 331986337
• Report Number: 3002809144-2024-00004
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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 Expiration Date: 01/02/2024
• Device Catalogue Number: 08P07-32
• Device Lot Number: 51721BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HIV COMBO CAL, 08P07-01, (B)(6); ALNTY I HIV COMBO CAL, 08P07-01, (B)(6)