MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD 22 SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number	09H59-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported their finger was punctured while cleaning the cell dyn emerald 22 open tube analyzer.The customer stated the instrument was in the aspiration position and splashed a few drops of blood from the last sample being processed.The customer decided to clean the analyzer but mistakenly pressed the aspiration button on the instrument causing the aspiration needle to come out and puncture the customer¿s finger.The customer indicates that they were wearing gloves and the needle punctured through the gloves and injured their finger.The customer followed their internal protocol and started taking retroviral medication (acriptega).No further medical treatment or harm to the user was reported.No further impact to patient management reported.
Event or Problem Description
The customer reported their finger was punctured while cleaning the cell dyn emerald 22 open tube analyzer.The customer stated the instrument was in the aspiration position and splashed a few drops of blood from the last sample being processed.The customer decided to clean the analyzer but mistakenly pressed the aspiration button on the instrument causing the aspiration needle to come out and puncture the customer¿s finger.The customer indicates that they were wearing gloves and the needle punctured through the gloves and injured their finger.The customer followed their internal protocol and started taking retroviral medication (acriptega).No further medical treatment or harm to the user was reported.No further impact to patient management reported.Updated on 16nov2023, to clarify that blood did not splash the customer but the instrument, which is why the customer decided to clean the instrument after she was done processing all samples.
Additional Manufacturer Narrative
B5 - describe event or problem: on 16nov2023, added information to clarify that blood did not splash the customer but the instrument, which is why the customer decided to clean the instrument after she was done processing all samples.The customer reported that while running samples, a few drops of blood splashed onto their cell-dyn emerald 22 (list number 09h59-01) instrument.After sample processing was completed, the customer decided the clean the instrument, and pressed the aspiration button by mistake.The aspiration needle came out and punctured his/her finger.The customer was wearing gloves and the needle went through the glove and injured his/her finger.Return testing was not performed as returns were not available.Increased complaint activity was not identified for the complaint issue.A review of ticket trending did not identify any related trends.A review of device history records did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Use error contributed to this event as the customer pressed the aspiration button by mistake when cleaning the instrument while it was in dif mode.Based on the investigation, cell dyn emerald 22 (list number 09h59-01), serial number (b)(6) is performing as intended, no systemic issue or product deficiency was identified.

• Brand Name: CELL-DYN EMERALD 22 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 17952500
• Report Number: 2919069-2023-00040
• Device Sequence Number: 6565122
• Product Code: GKZ
• UDI-Device Identifier: 00380740020286
• UDI-Public: 00380740020286
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K110381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09H59-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown