MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM NEXT ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number 06A36-34

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier multiple consists of (b)(6).(b)(4).A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

Donor ids (b)(6) generated reactive prism (b)(6) results but (b)(6) confirmatory results.Additional testing for ids (b)(6) were nat negative.No impact to patient management was reported.No specific patient information was provided.

Manufacturer Narrative

Evaluation of complaint data for the products and likely cause lots did not identify elevated complaint activity.Label reviews were performed and found them to adequately address the customer's issue.Additionally, review of the device history records for the likely cause lots did not reveal any issues related to the customer's observations.A review of the prism metrics field data for lot 57108m500 was also performed and found the (b)(6) rates to be 0.11% and 0.09%, which is less than the abbott prism (b)(6) package insert upper 95% confidence intervals of 0.38% and 0.37%, respectively.Additionally, field data was reviewed by customer site and the (b)(6) rates for lot 57108m500 in january 2016 and february 2016 were 0.07% and 0.06%, and 0.05% and 0.04%, respectively.Finally, the prism metrics field data from december 2015 (earliest manufacture date of the prism reaction tray likely cause lots 57127m500 and 57128m500) was also reviewed and the initial and repeat reactive rates for the three months were 0.10%/0.11%/0.11% and 0.09%/0.10%/0.09%, respectively.As a result, all of the (b)(6) rates under review were within package insert specifications; therefore, the product is meeting labeling claims for clinical specificity.There is no malfunction or product deficiency.

• Brand Name: PRISM NEXT ANALYZER
• Type of Device: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• 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: 5455396
• MDR Text Key: 39248943
• Report Number: 1628664-2016-00046
• Device Sequence Number: 1
• Product Code: MZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK970042
• 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: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06A36-34
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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