MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HIV AG/AB COMBO; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Catalog Number 04J27

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/20/2014

Event Type  malfunction  

Event Description

A laboratory technician was splashed in the eye with the (b)(4) assay.The technician was not wearing eye protection.The technician flushed their eyes using an eye wash station.No additional information has been provided regarding the technician.

Manufacturer Narrative

This report is being filed on an international product, list number 04j27 that has a similar product distributed in the us, list number 02p36.(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a batch record review, a search for similar complaints, and a review of labeling.Review of complaint text showed that the splash in the eye with the (b)(6) 2 control was related to incorrect use, since the user did not wear safety glasses when the issue occurred.The batch record review found no issues.There is no atypical complaint activity for the likely cause lot and the tracking and trending report review determined that there are no adverse trends and no non-statistical trends identified for the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information no malfunction and no product deficiency of the architect (b)(6) ag/ab combo assay, list number 04j27, was identified.

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 6520 5; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3808332
• MDR Text Key: 15109405
• Report Number: 3002809144-2014-00126
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 04J27
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR 03M74-01, SN (B)(4); ARCHITECT (B)(4) AG/AB CTRL 04J27-12, LOT 5844LI00; ARCHITECT (B)(4) AG/AB CTRL 04J27-12, LOT 5844LI00; ARCHITECT I2000SR 03M74-01, SN (B)(4)