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

Catalog Number	08H67-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the de-installation process of the cell dyn ruby analyzer on (b)(6) 2023, the technical service specialist (tss) (49-year-old male) was injured when moving the equipment.The tss was carrying out the process of demobilizing diagnostic equipment cell dyn ruby (serial (b)(6) and after uninstalling the equipment, the tss went to remove the equipment from the bench and position it on a cart for transportation.Due to the weight (approximately 100kg), it was not possible to move alone, so the tss requested help from a service provider from another company that works for the client to move the equipment from the bench (approximately 1.20m high) to a transport cart (approximately 0.20m high).When the tss lifted the equipment, he lost strength in his right arm letting the equipment fall to the floor.After a few minutes he regained strength and finished the task.The equipment was taken to the location for storage and subsequent collection from the customer.He felt pain in his right arm, which improved spontaneously.When he removed his coat, he saw that his biceps muscle was retracted and decided to seek medical attention at (b)(6) hospital where he was diagnosed with a tendon rupture.His extremity was immobilized and he underwent surgery to repair the injury on (b)(6) 2023 at (b)(6) hospital.His extremity was immobilized again for 45 days after surgery, and he is now receiving physical therapy and is on medical leave.The technical service specialist required surgery at (b)(6) hospital to repair the tendon, he is receiving physical therapy and is on medical leave.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
A review of all complaints and complaint trends for the cell-dyn ruby analyzer was performed.The review did not identify any adverse trends, and an increase in complaint activity was not identified.A review of the product historical data did not find a product issue related to the complaint incident.Labeling was reviewed and found to be adequate for the complaint issue.Based on the information within the complaint record, the device met performance specifications or otherwise performed as intended at the customer site.No deficiency of the device was identified.

• Brand Name: CELL-DYN RUBY 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: 18694715
• Report Number: 2919069-2024-00014
• Device Sequence Number: 12878369
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2010
• 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: Disability
• Patient Age: 48 YR
• Patient Sex: Male