MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO INFINITY; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Model Number	850000010
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported an issue concerning the tango infinity: the system liquid container intermittently lost its connection.Apparently, the sensor cable did break apart on the system liquid container causing intermittent level sensing issues.A new user did not disconnect the containers correctly and thus the wiring was exposed on the connectors due to the pulling.The customer clained to have received a very light electrical shock as she was reconnecting the container.She confirmed that no medical treatment was required, no marks, no other harm.Beside the power supply and the main switch, there is no high voltage used in the tango infinity system, the operating voltage is 24 v.The tango infinity was inspected by one of our field service engineers.Regarding the broken electrical connection on the system liquid container, he disconnected the system liquid level sensing wire.The field service engineer (fse) ensured that no high or unusual voltage was coming from the instrument's system liquid level sensing line.Additionally, the fse ensured no voltage was coming from the disconnected system liquid container, and ensured no electrical wires are exposed.He found no hint for a device malfunction.The risk management files of the instrument were reviewed.The files describes the following situation: the hazardous situation of an electric shock caused by defect power supply or cable from manufacturing or the situation that an operator touches a wire with broken insulation or inadequately grounded system is considered as potential risk for tango infinity.The defined risk control measure was the development according to common safety standards.With verification by emc tests (refer to test report test lab (nemko)) according to en 61326-2-6:2013 and en 61326-1:2013, electrical safety: iec 61010-1:2001 (second edition), the occurrence of a potential harm was considered to be unlikely.The risk/benefit was analyzed to be positive and accepted.Conclusion: based on the investigation the complaint was classified as undetermined.There is no sign for a technical malfunction for this this device, which can cause a higher voltage on the level sensing lines.According to the electrical safety check of the device design the device is to be seen as safe.The customer stated the shock was very light, causing no lasting marks, and no medical treatment was required.We are not able to decline or confirm this issue but there is not indications of a device malfunction, maybe there was an electrostatic discharge, or the customer got pecked by the stranded wire or the solder.As there was no hint for a technical malfunction, the device design passed all electrical safety check, the risk is already considered in the risk management file, no case reported about an issue before (this is a single occurrence), in this case no harm reported, no further steps were initiated.

• Brand Name: TANGO INFINITY
• Common Device Name: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 16589735
• Report Number: 9610824-2023-00011
• Device Sequence Number: 3022056
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719(11)180308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK150327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 850000010
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown