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

Model Number	09H39-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No specific patient identifier or demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer questioned results generated with the cell-dyn emerald.The customer did not provide full result data, however noted that a sample initially resulted with 7.3 for hgb, and was repeated as 18.0.After troubleshooting procedures (decontaminate probe, clean, backflush) were performed the sample was repeated with a result of 21.5 (12-16).No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) performed troubleshooting and replaced multiple tubing and the lysis straw as they were worn out from normal use.The rbc counting head, list number 8701687701, lot number unknown, was then replaced as it was clogged/obstructed.Following this, an auto gains adjustment was performed and the customer was advised to recalibrate the instrument.Precision and quality control was performed and the analyzer passed.A review of complaints related to the rbc counting head, list number 8701687701 was performed and did not find a product issue related to the complaint incident for this part.Review of tracking and trending for the rbc counting head, list number 8701687701 did not identify any trends.A review of the product quality history for the lot number using search of the corrective and preventive actions (capa) system did not identify issues associated with the customer¿s observation.Labeling was reviewed and found to be adequate.Based on the investigation no systemic issue or deficiency of the rbc counting head, list number 8701687701 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
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13925426
• Report Number: 2919069-2022-00008
• Device Sequence Number: 1790681
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/04/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/27/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown