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

Catalog Number 09H39-01

Device Problem High Test Results (2457)

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

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information, 1.Patient identifier- multiple = (b)(6), date of birth: (b)(6) 2019 and (b)(6), date of birth: (b)(6) 2019.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided.

Event Description

The customer reported falsely increased wbc counts on two patients generated on the cell dyn emerald while doing a comparison to the cell dyn ruby analyzer.The results provided were: on (b)(6) 2019 original (b)(6) on emerald = 47.9gpt/l; second sample same patient, (b)(6) on ruby = 20.0 gpt/l / on the emerald = 19.9gpt/l /on the ruby = 33.7* 10e9/l / retested on ruby with rrbc mode = 20.0*; second patient (b)(6) on emerald = 56.9 / 76.0 / original sample not enough left so redrawn, on emerald = 29.9* / on ruby = 13.4* / in noc mode =12.2*.There was no reported impact to patient management.Per the emerald and ruby operations manual the (*) flag invalidates the results.Upon discussion with customer the samples are from babies which contain lyse resistant rbcs.

Manufacturer Narrative

The complaint text stated samples were from infants which contain lysis-resistant rbc.This explains the wbc results on the cell-dyn emerald being too high.When these samples were measured on the cell-dyn ruby they exhibit elevated wbc results with an rrbc alarm.A review of product historical data did not identify any trends or abnormal complaint activity for this issue.A review of the customer's data found that the cd ruby generated rbc morph flags which indicates rrbcs are suspected to be present.There was a discrepancy in wbc results generated on the cd emerald compared to the cd ruby, however, the cd emerald generated count invalidation (*) flags.Per the cd emerald operator's manual, count invalidation (*) flags require the customer to follow their laboratory's review criteria or review a stained smear to confirm the differential results and verify the wbc count.Additionally, redrawing the patient and/or retesting the specimen may be necessary.A review of the service history for the cell-dyn emerald, serial number (b)(4), was performed and no contributing factors to the complaint could be identified.Based on the investigation no product deficiency was identified for the cell-dyn emerald, serial number (b)(4).

• Brand Name: CELL-DYN EMERALD ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8584216
• MDR Text Key: 169925721
• Report Number: 2919069-2019-00054
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• PMA/PMN Number: K081495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1