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

Catalog Number	02H31-01
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
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.Additional information (b)(6).
Event or Problem Description
The customer reported sample identification mismatch on the cell dyn 3700.(b)(6) was read as (b)(6) by the analyzer.Per the log, it appears that (b)(6) was run two times.The initial (b)(6) run generated results which match with the repeat run of (b)(6).The initial results were reported to the physician but no treatment was given based on those results.The second run of (b)(6) was more in line with that patient's historical results.There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
The customer reported sample identification mismatch on the cell-dyn 3700.Sid (b)(6) was read as sid(b)(6) (seq.5967) by the analyzer.Per the log, it appears that sid (b)(6) was run a second time (seq.5968), but the second run was more in line with the second patient's historical results.The initial run, seq.5967, generated results which match with the repeat run of sid(b)(6) on seq.5972.Return testing was not completed as returns were not available.A review of product historical data did not identify any trends or customer complaints for this issue.A review of the cell dyn 3700 labeling adequately addresses messages and flags that are used to alert the operator.Instructions for interpreting all flags and numeric, scatter, and histogram data should be incorporated into the laboratory's procedure and used to determine the need for further action and/or review of results.Based on this investigation no product deficiency was identified for the cell dyn 3700 sl, list number 02h31-01, serial number (b)(4).

• Brand Name: CELL-DYN 3700 SL ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6945258
• Report Number: 2919069-2017-00140
• Device Sequence Number: 796067
• Product Code: GKZ
• UDI-Device Identifier: 00380740002725
• UDI-Public: 00380740002725
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K980614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: 02H31-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1