MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME HIV-1 AMP REAGENT KIT; TEST, HIV DETECTION

Catalog Number 6L18-90

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem Eye Injury (1845)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

Note: lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that realtime hiv-1 assay list number 02g31-10 is similar to us fda approved realtime hiv-1 assay list number 06l18-90.

Event Description

The customer reported splashing of re-suspended blood in dbs (dried blood spot) buffer from a patient sample's dbs card in one of the laboratory technician's eyes.The event occurred when running abbott realtime hiv-1 dbs assay.The laboratory technician explained that a sample rack with tubes containing eluted dbs samples slipped from his grip, and eluate from one tube splashed into one of laboratory technician's eyes.The laboratory technician rinsed the eye at the eye wash station and notified his supervisor.The lab technician was not wearing goggles at the time of the event, but he had other ppe (personal protective equipment) such as a laboratory coat and gloves.As per lab safety procedures after exposure to infectious/potential infectious material, the laboratory technician notified his safety officer and has started with (b)(6).The laboratory technician is a (b)(6) male.Upon follow-up with the customer, the laboratory technician confirmed that he is on (b)(6), but he was experiencing side effects of mild diarrhea and nausea.The technician has continued to work with no additional reports of additional side effects.No patient was involved; injury was sustained by an abbott realtime hiv user ((b)(6) male).The incident is being reported to fda because the incident occurred in (b)(6) using realtime hiv-1 list number 02g31-10 which is same/similar to us fda approved realtime hiv-1 list number 06l18-90.

Manufacturer Narrative

Investigation into this complaint included evaluation of labeling review, quality data review, and complaint history.The results of the investigation are summarized as follows: labeling review: this labeling review concluded that the related labeling is sufficient to address the reported complaint.Quality data review: the capa review of abbott msample preparation system dbs buffer kit (list 09n02-001) and abbott realtime hiv-1 amp rgt kit (list 02g31-010) was performed, and it did not identify any records related to a personal injury or anything splashing into someone's eye.Complaint history review: complaint history review did not identify any additional complaint tickets related to the reported issue for abbott msample preparation system dbs buffer kit (list 09n02-001) or abbott realtime hiv-1 amp rgt kit (list 02g31-010).Based on the results of the investigation elements, a product deficiency for abbott msample preparation system dbs buffer kit list 09n02-001 and abbott realtime hiv-1 amp reagent kit (list 02g31-010) was not identified.

Manufacturer Narrative

Date of report was corrected from 7/11/2019 to 7/12/2019.

• Brand Name: ABBOTT REALTIME HIV-1 AMP REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 8654536
• MDR Text Key: 146629027
• Report Number: 3005248192-2019-00004
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6L18-90
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention