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

Catalog Number 04J27-32

Device Problem Leak/Splash (1354)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

The customer was splashed on the skin in the face with the architect hiv ag/ab reagent.The skin was washed with water and not medical treatment was needed.No impact to patient management was reported.No additional impact or harm to the customer was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint investigation for the user accidently splashing architect hiv ag/ab reagent in his/her face included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed 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.A review of similar complaint by lot indicates that reagent lot 49563be00 performs as expected for the product.Trending review did not identify any related trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 49563be00 and the complaint issue.Labeling was reviewed and found to be adequate.The issue most likely occurred due to handling error.Based on the investigation the architect hiv ag/ab reagent lot 49563be00 is performing as intended, no systemic issue or deficiency of the architect hiv ag/ab reagent was identified.

Event Description

The customer was splashed on the skin in the face with the architect hiv ag/ab reagent.The skin was washed with water and not medical treatment was needed.No impact to patient management was reported.No additional impact or harm to the customer was reported.

• Brand Name: ARCHITECT 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: 18030584
• MDR Text Key: 326862537
• Report Number: 3002809144-2023-00453
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 04J27-32
• Device Lot Number: 49563BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR RECONDIT KO, 03M74-65, ISR06015; ARC I2000SR RECONDIT KO, 03M74-65, ISR06015