MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HIV O PLUS; HIV-1 AND HIV-2 ANTIBODIES

Catalog Number 03D34-48

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2014

Event Type  malfunction  

Event Description

The customer reported an increase in the number of (b)(6) results ((b)(6) with the elisa method) when testing patient samples with the abbott prism (b)(4) plus assay.The customer indicated that this issue resulted in a disqualification of said blood donors.No impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, list number 03d34, that has a similar product distributed in the us, list number 03l68.(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The customer complained about an increased high reactive rate since (b)(6) 2014, when he started using prism hiv o plus, lot number 39004q500.A product evaluation was performed in order to investigate this issue.Reagent lot 39004q500 was evaluated along with prism reaction tray lot 39194m500 as this reaction tray lot is made from the same lot of glass fiber matrix component of reaction tray lot 39287m500 (the lot in use when the customer observed the reported issue) ticket searches determined that there is a normal complaint activity and the tracking and trending report review determined that there are no related adverse or non-statistical trends.A review of labeling concluded that the issue is sufficiently addressed in the labeling.Based on the evaluation results, no product deficiency was identified.

• Brand Name: PRISM HIV O PLUS
• Type of Device: HIV-1 AND HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• 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: 4337917
• MDR Text Key: 5145286
• Report Number: 1415939-2014-00245
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2015
• Device Catalogue Number: 03D34-48
• Device Lot Number: 39004Q500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM ANALYZER: LIST NUMBER 06A36-04, SN (B)(4); PRISM ANALYZER: LIST NUMBER 06A36-04, SN (B)(4)