MAUDE Adverse Event Report: MCKESSON ISRAEL LTD. MCKESSON CARDIOLOGY ECG MANAGEMENT

Model Number	13.2.1.
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation to determine whether the device has malfunctioned.Change healthcare will provide a follow up report to the agency once additional information is available.
Event or Problem Description
A physician reported that the oncology medical staff delayed a medication administration to a pediatric patient due to prolonged automated qtc values that were presented in a report created by the mckesson ecg management system.The reporting physician further claims that following his consultation the patient eventually received the medication and is now receiving appropriate care.
Event or Problem Description
A physician reported that the oncology medical staff delayed a medication administration to a pediatric patient due to prolonged automated qtc values that were presented in a report created by the mckesson ecg management system.The reporting physician further claims that following his consultation the patient eventually received the medication and is now receiving appropriate care.
Additional Manufacturer Narrative
Mckesson cardiology ecg management displays the ecg waveforms along with ecg intervals and measurements.The measurements can be displayed by one of the following configurations: 1.Glasgow university interpretive algorithm, which is a widely used algorithm for automated ecg.2.Importing the measurement value from an ecg cart, which is a different device communicating with the mckesson cardiology ecg management system.In addition, the user can manually measure the intervals using a measurement tool and edit the value which is displayed by the selected option (glasgow or cart).The reporting physician claimed that the automatic measurement of the qt interval presented a falsely prolonged value.Change healthcare has unsuccessfully made multiple attempts to contact the customer to identify which configuration was used when the reported incident occurred (glasgow/ cart).Change healthcare has re-tested the ecg management qt interval calculation performed by glasgow algorithm.Testing against the product specifications passed successfully with the correct results.The reporting physician claimed that the medical staff based their decision to delay the administration of the medication on the automated qt value displayed.The reporting physician further stated that following his review of the ecg waveforms and interval, the patient was prescribed medication.The change healthcare ecg management user guide cautions that the over- reading physician must always rely on clinical judgment in concluding a diagnosis for the patient.The company concluded that the system performed as intended and no device malfunction occurred.

• Brand Name: MCKESSON CARDIOLOGY ECG MANAGEMENT
• Common Device Name: MCKESSON CARDIOLOGY ECG MANAGEMENT
• Manufacturer (Section D): MCKESSON ISRAEL LTD.; 26 harokmim st. azrieli center; building a; holon, 58858 49; IS 5885849
• MDR Report Key: 10398464
• Report Number: 9616760-2020-00003
• Device Sequence Number: 2618847
• Product Code: DQK
• UDI-Device Identifier: 80010939040011
• UDI-Public: (01)80010939040011(10)130201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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 Model Number: 13.2.1.
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: Other