MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 CS ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number	02H30-01
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	09/15/2017
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.An evaluation is in process.
Event or Problem Description
The customer observed discrepant neutrophil patient results while using the cell-dyn 3700 analyzer.The following data was provided for the patient.Sid (b)(6) initial 0.00 (0.00%), repeat 8.46 (88.6%).No impact to patient management was reported.
Additional Manufacturer Narrative
The customer stated that the cancer patient population tested by the cancer center runs abnormal differential results.Further issue review showed that for the affected test, the neutrophils were misclassified as monocytes and basophils; however, the instrument also generated multiple flags [vlym/blast, dflt(ne)], and dispersional data alerts for neutrophils, monocytes, and basophils.The flagging generated for the abnormal results required further verification.An abbott customer support specialist was dispatched to the account and proactively replaced the flow cell assembly [woc flow cell assembly with mounting plate (part 8921145201)] and the optical bench assembly [optical bench assembly, cd3500-3700 (part 8921166002)].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, a labeling review, and an instrument service 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 and the product labeling includes instructions that further verification is required for the observed abnormal results flags generated.Service history review identified no contributing factors to the customer issue.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: CELL-DYN 3700 CS ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6938093
• Report Number: 2919069-2017-00136
• Device Sequence Number: 718948
• Product Code: GKZ
• UDI-Device Identifier: 00380740002688
• UDI-Public: 00380740002688
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980614
• 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): 10/16/2017

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: 02H30-01
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR