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

Catalog Number 09H39-01

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation which included reviewing historical data, no product deficiency was identified for the cell-dyn emerald instrument, for the complaint issue.The field service representative (fsr) found syringe movement was not as expected on the cell-dyn emerald.The fse flushed and lubed the syringes with stable precision.Additionally, preventative maintenance was performed.Review of complaint information found quality control (qc) was biased for hemoglobin (hgb) and out of range high for red blood cell (rbc).A review of the product labeling concluded that the issue is sufficiently addressed.A review to identify adverse trends for a product issue related to the complaint incident was not identified.Use error may have contributed to the customer's issue as preventative maintenance was not done on the instrument since january 2015.No product deficiency was identified.

Event Description

The account generated falsely elevated hemoglobin on 2 patient samples processed on the cell-dyn emerald.Patient 1 generated cell-dyn emerald hemoglobin of 9.5 g/dl with a fingerstick sample but the patient generated hemoglobin of 6.5 with a venous at another facility.Patient 2 generated cell-dyn emerald hemoglobin of approximately 8 g/dl but the patient historically runs approximately 6.0 g/dl.No impact to patient management was reported.No specific patient information was provided.

• 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: 6546521
• MDR Text Key: 74584740
• Report Number: 2919069-2017-00082
• 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
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2012
• 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