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

Catalog Number	07H77-01
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2017
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 observed falsely elevated white blood cell (wbc) results while using the cell-dyn 1800 analyzer.The following data was provided for one patient.The customer uses reference range 4.8 to 10.8 k/ul.Initial 75.8, repeat 17.9 the customer stated the repeat result was consistent with patient history.No impact to patient management was reported.
Additional Manufacturer Narrative
An abbott field service engineer was dispatched to the account and adjusted the analyzer detergent cap (part 03h92-01) and diluent cap (part 92163-01) to allow airflow into the reagent containers to address the flow and clog issue reported by the customer.No damaged parts were reported.The analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a labeling review.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.The diagnosis and treatment of the patient was not provided and a definitive cause for the different results could not be determined.The patient specimen was not available for return and the true value for this specific patient sample could not be verified.The customer stated that multiple flags for all runs for the patient specimen were observed, including the rm flag.The operator manual states that the rm flag can be caused by interfering substances including nucleated red blood cells (rbc), platelet clumps, giant platelets (plt), or incomplete lysis of rbc in the specimen.The presence of interfering substances in the specimen could not be eliminated.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not 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: 6624636
• Report Number: 2919069-2017-00094
• Device Sequence Number: 19028038
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/23/2017

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: 05/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1