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

Catalog Number	07H77-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated falsely depressed hemoglobin on a patient sample processed multiple times on the cell-dyn 1800.Initially, hemoglobin of 9.0 g/dl but repeated 7.7, 7.0, 6.2, 5.6, 5.1 g/dl.The account uses a normal range of 12 to 18 g/dl and under 8 g/dl is critical low.The sample was repeated on the cell-dyn emerald with expected hemoglobin of 11 g/dl.No impact to patient management was reported.No specific patient information was provided.
Additional Manufacturer Narrative
The evaluation included review of product historical data and product labeling.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.There are several factors that could affect the results of different parameters.Instrument troubleshooting was performed by the customer with phone assistance from customer support.The following troubleshooting was performed: exercising the valves and massaging the pinched tubing.Flushing the t-fittings an tubing attached to the wbc mixing chamber.Drain/fill the rbc and wbc mixing chambers 2 times.Running multiple background counts the customer reported precision check and quality control were within specifications after the troubleshooting performed on the analyzer.Instrument troubleshooting resolved the complaint issue and testing of patient samples was resumed.The cell-dyn 1800 operator's manual provides troubleshooting guide designed to guide the operator through a logical series of steps to obtain information regarding the nature of the problem.A review of the product labeling concluded that the issue is sufficiently addressed.Based on available information, the complaint incident was due to instrument status condition which was resolved by troubleshooting.The complaint incident was an instrument-specific issue for serial number (b)(4); therefore, a product deficiency was not identified for the cell-dyn 1800 analyzer.

• 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: 6098459
• Report Number: 2919069-2016-02302
• Device Sequence Number: 747807
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/17/2017

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: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1