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

Catalog Number 02H31-01

Device Problem Display Difficult to Read (1181)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Additional information (b)(6).

Event 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.

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
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6945258
• MDR Text Key: 90293410
• Report Number: 2919069-2017-00140
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740002725
• UDI-Public: 00380740002725
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K980614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02H31-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1