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)
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 observed falsely elevated wbc results on the cell-dyn cd1800 analyzer.The following data was provided: wbc of 99 k/ul, which repeat in the normal range of 4.6-10.2 k/ul.Sid (b)(6) initial wbc 47.1 k/ul, which repeated in the normal range and sid (b)(6) wbc 57.7 k/ul, which also repeated in the normal range.There was no impact to patient management.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures namely, cleaning sample syringe, flushing all reagent lines, reseating syringes, inspection of lines for crinks and bubbles, cleaning of wbc aperture plate with bleach solution using an aperture brush, and massaging and re-seating the tubing in the normally closed valve 3-1.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Additional Manufacturer Narrative
Additional discrepant data was provided for sid (b)(4) initial wbc 70.7, repeat 10.2, 12.4, 13.7.There was no impact to patient management reported.An evaluation is still in process.A follow up report will be submitted when the evaluation is complete.

• 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: 6061642
• Report Number: 2919069-2016-02278
• Device Sequence Number: 18917094
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/18/2016

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 Catalogue Number: 07H77-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/06/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 11/14/2016; 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1