MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN EMERALD CLEANER

Catalog Number 09H46-02

Device Problems Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

A product recall letter was issued to all cell-dyn emerald customers who have received cell-dyn emerald cleaner (lots 6853, 6901, 6953, 6991, 7024, 7027, 7044, 7082, 7110 and/or 7119).The letter informs the customer of the issue regarding the potential for out of range controls.The letter instructs the customer to discontinue use of the suspected lot and destroy any remaining inventory.The customer is instructed that if they do not have replacement material available, they can continue to use the lot until they receive replacement material as long as their controls are in range.The customer is instructed to perform the decontamination procedure per the operator's manual.The cause for the qc material out-of-range low issue has been traced to the manufacturing process for raw material used in the cell-dyn emerald cleaner.

Event Description

The customer stated that they were getting all dashes for qc results.Upon review of qc data history provided by the customer, it was determined that plt controls had been out of range low with the use of cell-dyn emerald cleaner reagent lot number 6953.No adverse impact to patient management was reported.

• Brand Name: CELL-DYN EMERALD CLEANER
• Type of Device: CELL-DYN EMERALD
• 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: 6835881
• MDR Text Key: 84645076
• Report Number: 2919069-2017-00129
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740020132
• UDI-Public: 00380740020132
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 09H46-02
• Device Lot Number: 6953
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2919069-03/24/16-001-R
• Patient Sequence Number: 1