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

Catalog Number	09H46-02
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer was experiencing rbc controls out of range low with the use of cell-dyn emerald cleaner reagent lot number 7110.No adverse impact to patient management was reported.

• Brand Name: CELL-DYN EMERALD CLEANER
• Common Device Name: CELL-DYN EMERALD
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6187612
• Report Number: 2919069-2016-02315
• Device Sequence Number: 82259
• Product Code: GKZ
• UDI-Device Identifier: 00380740020132
• UDI-Public: 00380740020132
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 09H46-02
• Device Lot Number: 7110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2919069-03/24/16-001-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CELL-DYN EMERALD ANALYZER 09H39-01 SN (B)(4)