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Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 15may2019.No further follow-up is planned.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device could not be pushed down and the pen body near the cartridge holder was cracked.The patient experienced increased blood glucose.The investigation of the returned device (batch 0906d04, manufactured june 2009) found the needle thread of the cartridge holder was broken, the pen housing was cracked near the bezel, and the soft touch was partly de-bonded.The damage to the cartridge holder rendered the device non-functional.Malfunction confirmed.However, testing of the device using a designated cartridge holder found the device met functional requirements.The core instructions for use states if any of the parts of your humapen ergo ii appear broken or damaged, do not use.It further instructs the patient to not use the device if it appears broken or damaged and to contact lilly or their healthcare provider for a replacement pen.The patient obtained the device in (b)(6) 2011 (9 years ago).The user manual states the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The damage to the cartridge holder, rendering the device non-functional, is consistent with damage while in the field.Additionally, the patient used the device beyond its approved use life.These misuses may be relevant to the event of increased blood glucose.
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Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by two consumers via a patient support program (psp) with additional information from nurse, concerned a female patient of unspecified age and origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30, 100iu/ml) unknown formulation, at unknown dose and frequency subcutaneously, for the treatment of diabetes, beginning in 2010 and insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix 50/50, 100 u/ml) at unknown dose and frequency subcutaneously, for the treatment of diabetes, beginning on an unknown date, both using humapen ergo ii beginning in 2012.On an unknown date, after starting human insulin isophane suspension 70%/ human insulin 30% and insulin lispro protamine suspension 50%/ insulin lispro 50%, her blood sugar was high (reported as diabetes mellitus) due to which she was hospitalized.On (b)(6) 2019, the pen body of humapen ergo ii was cracked near the cartridge holder (pc (b)(4), lot 0906d04).As of (b)(6) 2019, she was discharged and her blood glucose was well controlled.The human insulin isophane suspension 70%/ human insulin 30% was stopped on an unknown date due to unspecified reason.Information regarding corrective treatment, status of human insulin isophane suspension 70%/ human insulin 30% treatment after discontinuation was not reported.The insulin lispro protamine suspension 50%/ insulin lispro 50% was continued.The user of the humapen ergo ii and his/her training status was not provided.The general humapen ergo ii duration of use was not reported but it was started in 2012.The suspect humapen ergo ii duration of use was reported as over three years.The suspect device, which was manufactured in jun2009, was returned to the manufacturer on 28feb2019.The reporting nurse and consumers did not provide the opinion of relatedness between events and human insulin isophane suspension 70%/ human insulin 30%, insulin lispro protamine suspension 50%/ insulin lispro 50% and humapen ergo ii.Update 01-mar-2019: this case was determined to be non-valid as there was no identifiable adverse event.Update 11-mar-2019: additional information received from the initial reporter via psp on (b)(4) 2019.Tr number was received.No new information about the hospitalization reason was received, so this case continued as not valid since there was no identifiable adverse event.Update 29-mar-2019: information received from affiliate on 28-mar-2019 was the call showed sorry, please hold on.The subscriber you dialed was busy.No new information was received, so this case continued as not valid since there was no identifiable adverse event.Update 26-apr-2019: the case was initially determined to be non-valid.Additional information was received from initial consumer via psp on (b)(4) 2019 which contain valid event.Updated ergo ii as suspect device.Added nurse reporter, serious event of blood sugar increased, two laboratory data for blood glucose.Deleted non-valid event of hospitalization.Updated narrative with new information.Update 01may2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 15may2019: additional information received on (b)(4) 2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(4) (eu/(b)(4)) device information, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for pc (b)(4) associated lot of 0906d04 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.
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