MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP CENTRIFUGE MODULE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q03-01

Device Problem Mechanical Jam (2983)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

The abbott field service representative (fsr) was on site visit due to glp centrifuge wheels not moving properly when the customer was doing maintenance.During the site visit at customer site when changing the wheels, the glp centrifuged slide on the fsr left hand and damaged fourth finger.The fourth finger got swollen and he went to see doctor for swollen finger treatment.The x-ray done and determined bone fracture on fourth finger.The doctor prescribes him aescin ointment to apply on finger.The fsr have bandage on finger.He will be on leave for four weeks.There was no blood just swollen finger.No other treatment or medication required.The fsr is doing ok.There was no impact to patient management.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.H10: this report is being filed on an international product, list number 06q03-01 that has a similar product distributed in the us, list number 04z96-51.

Manufacturer Narrative

The glp technical group performed a review of the issue for glp centrifuge wheel pair (part number g-41340-01) for the glp centrifuge module (cm), serial (b)(6)).Based on the available information within the complaint text and ticket system, glp technical group concluded there were no other tickets found to be similar to the current issue; no adverse trend was identified.A review of tracking and trending data did not identify any related trends for the product for the issue.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information.The aas team determined that the fsr followed the available service instructions to replace the centrifuge wheels and found that the centrifuge was placed on the rails of the centrifuge door.Review of the available service documentation regarding safety and handling instructions of the centrifuge during wheel replacement showed that inadequate instructions were provided when securing the centrifuge while the wheels are in place.Based on the complaint, the information suggests that no systemic issue or product deficiency was identified for glp centrifuge wheel pair for the glp centrifuge module.

Event Description

The abbott field service representative (fsr) was on site visit due to glp centrifuge wheels not moving properly when the customer was doing maintenance.During the site visit at customer site when changing the wheels, the glp centrifuged slide on the fsr left hand and damaged fourth finger.The fourth finger got swollen and he went to see doctor for swollen finger treatment.The x-ray done and determined bone fracture on fourth finger.The doctor prescribes him aescin ointment to apply on injured finger.The fsr have bandage on finger.He will be on leave for four weeks.There was no blood just swollen finger.No other treatment or medication required.The fsr is doing ok.There was no impact to patient management.

• Brand Name: GLP CENTRIFUGE MODULE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18641549
• MDR Text Key: 334613979
• Report Number: 3023268435-2024-00003
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 380740186647
• UDI-Public: (01)380740186647
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K213486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 06Q03-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability