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

Catalog Number	07H77-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6312684
• Report Number: 2919069-2017-00008
• Device Sequence Number: 540000
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K030513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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 Catalogue Number: 07H77-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1