MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS

Catalog Number 07C18-34

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).(b)(6).An evaluation is in-process.

Event Description

While the customer was preparing to perform the qc process, the hbsag quality control dripped out and splashed into their eyes.The technician flushed their eyes with water and had a blood draw to test for infectious diseases (hbv, hcv, hiv and tp).No additional information was provided regarding this operator.

Manufacturer Narrative

Additional information was provided on 10/11/2017.Concomitant medical products: size code was updated and lot number provided on 10/09/2017.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Return material was not available.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate which includes instruction to wear protective gloves/protective clothing /eye protection.Based on the available information a product deficiency was not identified for the architect anti-hbs reagent list number (b)(4).

Event Description

On (b)(6) 2017 update: the customer was not wearing protective eyewear or glasses while operating.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6923184
• MDR Text Key: 89940442
• Report Number: 3008344661-2017-00089
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P050051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07C18-34
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1