Model Number MS9697 |
Device Problems
Failure to Deliver (2338); Physical Resistance/Sticking (4012)
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Patient Problems
Hyperglycemia (1905); Weight Changes (2607)
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Event Type
Injury
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Manufacturer Narrative
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Reportable malfunction/incident identified.Investigation in progress.A follow-up report will be submitted when the final evaluation is completed as necessary.
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Event Description
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Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old male patient of an unspecified origin.Medical history and concomitant medications were not provided.The patient received human insulin (rdna) (humulin r) cartridge, via humapen savvio (pink), beginning on an unknown date.Information regarding dosage regimen, route of administration and indication for use was not provided.On an unknown date, after starting human insulin therapy, he had some problems in his heart.He had extra heart beats, valve reflux and atrial fibrillation (reported as zabzaba osoneya) due to which he was hospitalized on an unknown date.A catheter was put since (b)(6) 2018.More information regarding hospitalization was not provided.On an unknown date, he could hardly release any insulin dose as the screw of pen was very stiff and it released air instead (product complaint (b)(4), lot number 1401v03).His blood glucose level was high (units, values and reference ranges not provided).Since (b)(6) 2019, he felt that he had lost a lot of weight (units, values and reference ranges not provided).Sometimes he felt a drop in level of sugar in blood as it reached 52 mg/dl (reference ranges not provided) and 58 mg/dl (reference ranges not provided).Information regarding corrective treatment, outcome of the events and status of human insulin therapy was not provided.The operator of the humapen savvio (pink) was patient and his training status was not provided.The general humapen savvio model duration of use was not provided and suspect humapen savvio model duration of use was started approximately a year ago.The suspect humapen savvio (pink) device associated with product complaint (b)(4) was returned to the manufacturer on 04jun2019.The reporting consumer did not provide relatedness assessment between the events and human insulin therapy and its humapen savvio.Update 06-may-2019: information received from affiliate on 24-apr-2019 regarding product complaint (pc) number (b)(4).Pc was already processed.Upon review of initial information received on 21-apr-2019, updated preliminary comment.No medically significant information was received and no other changes were made to the case.Edit 06-may2019: upon internal review of the initial information in addition to a clarification received from the affiliate on 05may2019: updated heart rate increased event to atrial fibrillation.No further changes were performed.Update 13-may-2019: information was received from affiliate on 28-apr-2019 regarding reason for hospitalization, they confirmed it was due to a catheter placement and not due to glucose level.No new event or additional medically significant information was provided.Update 19jun2019: additional information was received from the global product complaint database on 04jun2019.It was reiterated that the pc (b)(4) was linked to lot number 1401v03 relating to the humapen savvio (pink) device.Updated malfunction from unknown to yes/cirm, preliminary comments, and device return status to returned to manufacturer.Added medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, and date returned to the manufacturer for the suspect humapen savvio (pink) device associated with product complaint (b)(4).Edit 20jun2019: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.
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Event Description
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Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 20-year-old male patient of an unspecified origin.Medical history included some chest allergy and shortness in his breath (when he was child) and concomitant medications were not provided.The patient received human insulin (rdna) injections (humulin r) cartridge, via humapen savvio (pink), beginning on an unknown date, in (b)(6) 2018.Information regarding dosage regimen, route of administration and indication for use was not provided.On an unknown date, after starting human insulin therapy, he had some problems in his heart.In (b)(6) 2019 (conflicting information), he suffered from dysnea (shortness in his breath) and he was admitted to the hospital, where he was diagnosed that it was angina (possibly: angina pectoris).As a corrective treatment, he took sublingual tablet for it.All the required lab investigations such as echo and cardio gram were performed (values not provided).He also had enlargement in the cardiac muscle, and there was a hole in the heart.He also had extra heart beats, valve reflux and atrial fibrillation (reported as zabzaba osoneya) due to which he remain hospitalized.A catheter was put since (b)(6) 2018.More information regarding hospitalization was not provided.On an unknown date, he could hardly release any insulin dose as the screw of pen was very stiff and it released air instead (product complaint (b)(4), lot number 1401v03).His blood glucose level was high (units, values and reference ranges not provided).Since (b)(6) 2019, he felt that he had lost a lot of weight (units, values and reference ranges not provided).Sometimes he felt a drop in level of sugar in blood as it reached 52 mg/dl (reference ranges not provided) and 58 mg/dl (reference ranges not provided).Information regarding corrective treatment, outcome of the events and status of human insulin therapy was not provided.The operator of the humapen savvio (pink) was the patient and his training status was not provided.The general humapen savvio model duration of use was not provided and suspect humapen savvio model duration of use was started approximately a year ago.The suspect humapen savvio (pink) device, which was manufactured in (b)(6) 2014 and associated with product complaint (b)(4), was returned to the manufacturer on 04jun2019.The reporting consumer did not provide relatedness assessment between the events and human insulin therapy and its humapen savvio.Update 06-may-2019: information received from affiliate on 24-apr-2019 regarding product complaint (pc) number (b)(4).Pc was already processed.Upon review of initial information received on 21-apr-2019, updated preliminary comment.No medically significant information was received and no other changes were made to the case.Edit 06-may2019: upon internal review of the initial information in addition to a clarification received from the affiliate on 05may2019: updated heart rate increased event to atrial fibrillation.No further changes were performed.Update 13-may-2019: information was received from affiliate on 28-apr-2019 regarding reason for hospitalization, they confirmed it was due to a catheter placement and not due to glucose level.No new event or additional medically significant information was provided.Update 19jun2019: additional information was received from the global product complaint database on 04jun2019.It was reiterated that the (b)(4) was linked to lot number 1401v03 relating to the humapen savvio (pink) device.Updated malfunction from unknown to yes/cirm, preliminary comments, and device return status to returned to manufacturer.Added medwatch fields with device information, the european and canadian (eu/ca) device information, and date returned to the manufacturer for the suspect humapen savvio (pink) device associated with product complaint (b)(4).Edit 20jun2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 25-jun-2019: additional information was received from the additional consumer reporter via the psp on 14-jun-2019.Added new consumer reporter.Added two medical histories.Added one serious event of angina pectoris.Updated details regarding events of heart valve incompetence and heart rate increased.Updated causality statement and narrative with new information.Update 26jul2019: additional information received on 25jul2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information.Added date of manufacturer for (b)(4) associated with lot 1401v03 of humapen savvio (pink) device.Corresponding fields and narrative updated accordingly.
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Manufacturer Narrative
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B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 26jul2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that when using a humapen savvio device, he could hardly release any insulin dose as the screw of pen was very stiff and it released air instead.He experienced non-serious events of increased and decreased blood glucose.Investigation of the returned device (batch 1401v03, january 2014) identified a broken bulkhead component, and found an oily substance present on the housing collar and the bulkhead subassembly.Spectroscopic analysis of the oily substance identified it to be consistent with a fatty acid based substance, such as lard oil.The fatty acid based substance, introduced in the field and not related to the manufacturing process, caused degradation of the bulkhead components, causing the device malfunction.Malfunction confirmed.Initial screening of the device also associated the case with the reportable malfunction "face clutch engagement failure." however, it was determined that this case was not associated with that reportable malfunction as the face clutch spring was normal.The core user manual provides instructions for proper care and storage of the device.It states, "do not use alcohol, hydrogen peroxide or bleach on the pen body or dose window.Also, do not cover in liquid or apply lubrication such as oil, as this could damage the pen." there is evidence of improper use.Foreign material contamination of the device occurred while in the field (not related to the manufacturing process).This misuse is relevant to the finding of bulkhead failure and may be relevant to the event of increased blood glucose.
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Search Alerts/Recalls
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