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 Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer states that one male patient (date of birth (b)(6)) diagnosed with unspecified thrombocytopenia generated a platelet result of 92 k/ul on (b)(6) 2018 for a sample (sid (b)(4)) tested on the cell-dyn emerald analyzer.The patient is currently on prednisone drug therapy.The patient then saw his primary care physician on (b)(6) 2018 who ordered a platelet count, which generated a result of 12 k/ul.The patient then was sent to the emergency department ((b)(6) 2018) where another platelet count was ordered and generated a result of 7 k/ul.The patient's drug administration was then adjusted per the emergency department's results.The customer states that on the day the result of 92 k/ul was generated on the cell-dyn emerald analyzer, all levels of quality control samples were within specifications.The customer did state that when a calibration of the analyzer was attempted the week before, it failed platelet precision results and now the analyzer is past due for calibration.The customer requested a service call.There was no adverse impact to patient management due to this issue.

Manufacturer Narrative

An abbott field service representative (fsr) visited the customer site to inspect the cell-dyn emerald analyzer.During the evaluation of the analyzer, both platelet and red blood cell (rbc) counts were out of specifications.The fsr bleached the analyzer and cleaned the rbc counting head.Subsequent instrument operations were acceptable.There were no returns available from the customer site.A review of complaint tracking and trending metrics was performed and identified no related adverse trends or systemic issues in conjunction with the complaint issue currently under evaluation.No non-conformances, potential non-conformances or deviations were identified.A review of the data submitted by the customer regarding the platelet counts was performed.The platelet counts provided were not unexpected as this parameter can change quickly, which would explain the change in results obtained on 21 february 2018.Also, it was found that a precision run performed by the customer had previously failed and therefore, no patient samples should have been run until the imprecision issue was resolved.The cell-dyn emerald operator manual provides information to address the current customer issue.Based on the available information from the customer site and the results of this evaluation, there is no evidence to reasonably suggest that a systemic issue or product deficiency exists.

• 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: 7332565
• MDR Text Key: 102213443
• Report Number: 2919069-2018-00018
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• 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: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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 Age: 78 YR