MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H00-01

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.

Event Description

The customer observed falsely elevated white blood cell (wbc) results while using the cell-dyn sapphire analyzer.The following data was provided for the same patient.Sid (b)(6) (diluted 1:3, tested (b)(6) 2017) 1.7 10e3/ul.Sid (b)(6) (undiluted, tested (b)(6) 2017) 10.4 10e3/ul.Both results were flagged with nvwbc (nonviable wbc) and varlym (variant lymphocytes).Microscopy results for the specimen was approximately 1000 (1 10e3/ul), and no atypical lymphocytes and no broken wbc were found in the microscopy.The results of the microscopy were reported.The patient is a baby, no age was provided.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, instrument log review, and labeling review.No adverse trend was identified for the customer issue.Log review did not identify any issues that contributed to the customer issue.Labeling was reviewed and found to be adequate.The complaint issue was related to a pediatric patient sample containing many nucleated red blood cells (nrbc).Nrbc is included in the cell-dyn sapphire operator manual as an interfering substance and condition that affect the wbc and wbc differential results.The instrument flagged the samples with nvwbc (nonviable wbc) and varlym (variant lymphocytes) and the cell-dyn sapphire operator manual and provided suggested action for these flags.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• 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: 7119396
• MDR Text Key: 95079138
• Report Number: 2919069-2017-00166
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051215
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H00-01
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2012
• 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