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

Catalog Number 08P07-32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/03/2022

Event Type  Injury  

Event Description

The customer reported that one of their laboratory assistants was performing qc on the alinity i processing module.The user put drops of the hiv ag/ab 1+ control into a secondary vial for testing.The user found bubbles in the secondary vial and decided to remove the bubbles with a syringe.After removing the bubble, and user decided to close the syringe needle with the cap and the user punctured their finger.After the incident, the user rendered medical treatment and received anti-hiv medication (tegrad/dolutegravir/ and truvada/tenofovir + emtricitabine) per the customer¿s laboratory protocol.The user was wearing personal protective equipment.There was no further harm / impact to the user or user safety and the user is doing ok.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 8p07-32 that has a similar product distributed in the us, list number 8p07-21 / -31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for puncture with needle containing alinity i hiv ag/ab combo control lot 38475be00, included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.A review of tracking and trending was reviewed and does not identify any related trends for the product for the issue.The device history record was reviewed and did not identify any non-conformances or deviations associated with the reagent lot.Based on the review of the issue, this represents a use error, since bubbles should be removed using an applicator stick and contaminated needles should not be recapped.Based on the investigation alinity i hiv ag/ab combo control reagent lot 38475be00 is performing as intended, no systemic issue or deficiency of the alinity i hiv ag/ab combo control was identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15206793
• MDR Text Key: 297672517
• Report Number: 3002809144-2022-00276
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: KZ
• 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: 09/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 08P07-32
• Device Lot Number: 39249BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 10/12/2022
• 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
• Treatment: ALNTY I HIV COMBO CTL, 08P07-10, 38475BE00.; ALNTY I HIV COMBO CTL, 08P07-10, 38475BE00.; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Outcome(s): Required Intervention