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

Catalog Number	08H67-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The abbott field service representative (fsr) was injured when installing a cell-dyn ruby analyzer.The fsr was assisting the movers with putting lifting handles on both sides of the analyzer while it was sitting on a pallet.The fsr was slightly lifting one side of the analyzer so the mover could slide the analyzer over to one side of the pallet, when the mover lifted the analyzer, it put all the analyzer¿s weight on the fsr¿s arm.The fsr heard a pop and felt extreme pain shoot through the left arm from bicep muscle down through the left arm.The fsr went to an urgent care facility where an x-ray found nothing was broken in the arm, however, the fsr went to an orthopedic doctor the next morning where an ultrasound concluded that the tendon for the left bicep muscle had torn away from the muscle and needed surgery to repair.The surgery was successful.
Additional Manufacturer Narrative
The complaint investigation for a field service representative (fsr) injury while installing a cell-dyn ruby analyzer, serial number (b)(6), included a review of information provided by the fsr, a search for similar complaints, ticket trending review, labeling review, and device history record review.While assisting movers in installing the ruby analyzer, the analyzer was shifted onto the fsr¿s arm, causing the tendon for the left bicep muscle to tear away from the bicep muscle.A review of the instrument history revealed no contributing factors described in this complaint.A review of historical data was done, and was adequate, with no trends found.Labeling was reviewed and sufficiently addresses safety hazards including the physical hazards of the weight of the analyzer, where hazards may exist.Based on the information provided and abbott diagnostics¿ complaint investigation, the cell-dyn ruby analyzer, serial number (b)(6), met performance specifications and performed as intended, and no systemic issue or deficiency was identified.
Event or Problem Description
The abbott field service representative (fsr) was injured when installing a cell-dyn ruby analyzer.The fsr was assisting the movers with putting lifting handles on both sides of the analyzer while it was sitting on a pallet.The fsr was slightly lifting one side of the analyzer so the mover could slide the analyzer over to one side of the pallet, when the mover lifted the analyzer, it put all the analyzer¿s weight on the fsr¿s arm.The fsr heard a pop and felt extreme pain shoot through the left arm from bicep muscle down through the left arm.The fsr went to an urgent care facility where an x-ray found nothing was broken in the arm, however, the fsr went to an orthopedic doctor the next morning where an ultrasound concluded that the tendon for the left bicep muscle had torn away from the muscle and needed surgery to repair.The surgery was successful.

• 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: 18699191
• Report Number: 2919069-2024-00016
• Device Sequence Number: 12611220
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K061667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: No
• 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): Initial
• Initial Date Received by Manufacturer: Not provided
• 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: 12/05/2022
• 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 Sex: Unknown