It was reported that the pump delivered inaccurate amount of medication (overdose) resulting in symptoms such as headache, feeling of heat, tachycardia at 110 without pump alarm.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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No product was returned.The investigation determined the most probable cause to be the the expulsor, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.B3, d4: udi, serial number, g5, and h4 are unknown, a1 and h6: health effects updated.
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