MAUDE Adverse Event Report: BD BIOSCIENCES BD FACSCANTO SYSTEM II UPGRADE V2.4; BD FACSCANTO CLINICAL SOFTWARE

Catalog Number 646603

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Misdiagnosis (2159)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

The incident occurred at the (b)(6) bd biosciences facscanto clinical software complaint (b)(4).A (b)(6) pt received a t-cell depleted hsct and engrafted with a very low t cell count.During follow up a sample (unclear whether marrow aspirate or pb) was gated automatically by the canto clinical software such that a very high level of t cell positivity was demonstrated.This turned out to be an incorrect result as the pt continued to have less than 1% t cells.Upon review, a very small cd 3+ subset was seen; however, the software algorithm did not recognize this small population as cd3+.Instead, it mistakenly drew the gate in the middle of a cd3- population resulting in a falsely elevated cd3+ population.According to dr (b)(6), the attending md for the flow lab, there was no adverse clinical impact to the pt as a consequence of this erroneous result.The incorrect result was manually re-gated in diva to reveal the continued presence of t-cell lymphopenia.Specifically, on (b)(6) 2014 and again on (b)(6) 2014, the bd facscanto clinical software categorized most cd3 lymphocyte population as positive on the pt samples.The result did not match pt medical history.After manual adjustment, the cd3% changed from 92.91% to 0.66%.The negative cd3% was confirmed by using bd facs diva software.

Manufacturer Narrative

• Brand Name: BD FACSCANTO SYSTEM II UPGRADE V2.4
• Type of Device: BD FACSCANTO CLINICAL SOFTWARE
• Manufacturer (Section D): BD BIOSCIENCES; 2350 qume dr.; san jose CA 95131
• Manufacturer Contact: eric claussen ; 2350 qume dr.; san jose, CA 95131 ; 4089546348
• MDR Report Key: 4577220
• MDR Text Key: 5486291
• Report Number: 2916837-2015-00001
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K062087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 646603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• 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
• Patient Outcome(s): Other