The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
|
Unomedical reference number (b)(4).On (b)(6) 2018 a male diabetic patient on pump therapy passed away due to diabetic ketoacidosis and coma.In the morning, patient woke up with a blood glucose level above 600 mg/dl and was vomiting.When patient went with the ems, the pump was still connected to the patient and they removed the pump.At that time, they noticed that the tubing that come out at the end, it was broken.Patient had a blood glucose above 1500 mg/dl when he died.No further information provided.
|