MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	09H39-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2020
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 reported a hemoglobin mismatch occurring on the cell-dyn emerald analyzer on an (b)(6) yr old male patient.Results provided: (b)(6) 2020 sid (b)(6) = 9.2 g/dl (reference range: 11-18 g/dl), another lab = 6.9 g/dl (reference range: 14-18 g/dl).All available patient information was included.Additional patient details are not available.No impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.No trends were identified for the customers issue.Labeling was reviewed and found to be adequate.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CELL-DYN EMERALD SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10886667
• Report Number: 2919069-2020-00036
• Device Sequence Number: 3170042
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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 Model Number: 09H39-01
• Device Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR