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

Catalog Number 09H39-01

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided an evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported a patient who received a defibrillation shock from her pacemaker when she entered the lab.Once she excited the lab her pacemaker returned to normal function and she did not seek medical assistance.The patient ((b)(6)) was approximately 8-10 feet from emerald instrument at time of issue.Other instruments in the lab area include clinitek urine analyzer, mini-ves sed rate analyzer, architect analyzer and ge home style refrigerator.The emerald operations manual includes this warning: caution do not use mobile telephones, wireless telephones, mobile radios, or any other radio frequency (rf) transmitting devices in the same room as the instrument.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.The emerald emissions of -6.7db and -5.7 db from 30-1000mhz are well below the limit of 47 db(uv/m) of (b)(4) standard requirement, therefore, the emerald would not cause any radio frequency interference (rfi) to other nearby electronics surrounding the cell-dyn emerald instrument if all of the other electronic devices are in compliance with the (b)(4) standard requirement.In addition, the instrument electrical and mechanical components are enclosed in metal outside covers (skin) to prevent interference from or emission of any electromagnetic interference or radioactive interference and are in compliance with emc/safety standards.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate and contains the following warnings: do not place the instrument near a centrifuge, x-ray equipment, video display terminal, computer, or copier.Caution: do not use mobile telephones, wireless telephones, mobile radios, or any other radio frequency (rf) transmitting devices in the same room as the instrument.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CELL-DYN EMERALD
• 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: 6447979
• MDR Text Key: 71323035
• Report Number: 2919069-2017-00068
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081495
• 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: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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
• Patient Outcome(s): Disability