MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 1800 ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 07H77-01

Device Problem High Test Results (2457)

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

Event Date 01/18/2017

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 reported the following results generated on a cell-dyn 1800 analyzer in their lab: hematocrit= 29.0%, hemoglobin= 9.3 g/dl.The sample was tested at another lab with the following results (analyzer system not provided): hematocrit= 28.7%, hemoglobin= 7.6 g/dl.Controls have remained within specifications.The customer retested the sample again with similar results.No suspect results were reported from the lab.There is no impact to patient management reported.

Manufacturer Narrative

Limited information was made available from the customer site for this evaluation.Numerous requests were made with no reply.Therefore, based on the limited data and information available, several factors could have affected the results seen at this customer site: clogging or blockage in the wbc and rbc mixing cups, pinched valves, tubing, or t-fittings, blockage due to salt build up, leaks in lines around hemoglobin flow cell, dirty flow cell due to organic build up and bubbles in the lines.In addition, the presence of an interfering substance and conditions affecting the results for this one patient's sample could not be eliminated.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.The cell-dyn 1800 system operator manual provides information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was identified.

• Brand Name: CELL-DYN 1800 ANALYZER
• 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: 6312684
• MDR Text Key: 67142375
• Report Number: 2919069-2017-00008
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030513
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07H77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2008
• 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