Model Number MS9697 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Hyperglycemia (1905)
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Event Type
Injury
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.
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Event Description
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Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by pharmacists who contacted the company to report adverse event and product complaint (pc), concerned a female patient of unknown age and origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml) from cartridge via reusable device (humapen savvio pink), about 6 units, for treatment of type 2 diabetes, beginning on an unknown date.Frequency and route of administration were not provided.On an unknown date after starting insulin lispro therapy, she was struggling to use the humapen savvio pink as it was not working for her and her sugar were not dropping.Her sugar levels reached about 30 mmol/l (no reference ranges were provided) (pc (b)(4)/ lot number 1404v08).She was not coping with the new model of the humapen savvio pink.The event of blood sugar increased was considered serious due to medical significance.Information regarding corrective treatment, outcome for the event and status of insulin lispro therapy was not provided.The patient was the operator of the humapen savvio pink and her training status was not provided.The humapen savvio pink model duration of use and suspect humapen savvio pink duration of use were not provided.The device was being retained for possible return and its return was expected.The initial reporting pharmacist did not relate the event to insulin lispro or the humapen savvio pink.The second reporting pharmacist did not provide a relatedness assessment for the event to insulin lispro or the humapen savvio pink.Update 04-may-2018: information received on 18-apr-2018 and 19-apr-2018 were processed together.Update 04may2018: additional information received on 20apr2018 from global product complaint database reiterated the lot number 1404v08 for product complaint (b)(4) relating to the humapen savvio (pink) device.Which was already present and correct in the case.Update 08may2018: updated medwatch 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 spontaneous case, reported by pharmacists who contacted the company to report adverse event and product complaint (pc), concerned a female patient of unknown age and origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml) from cartridge via a reusable humapen savvio pink device, about 6 units, for treatment of type ii diabetes mellitus, beginning on an unknown date.Frequency and route of administration were not provided.On an unknown date after starting insulin lispro therapy, she was struggling to use the humapen savvio pink as it was not working for her and her sugars were not dropping.Her sugar levels reached about 30 mmol/l (no reference ranges were provided).Reportedly, after priming the humapen savvio pink some insulin would come out from the needle ((b)(4) / lot number 1404v08).She was not coping with the new model of the humapen savvio pink.The event of blood sugar increased was considered serious due to medical significance.Information regarding corrective treatment, outcome for the event and status of insulin lispro therapy was not provided.The patient was the operator of the humapen savvio pink and her training status was not provided.The humapen savvio pink model duration of use and suspect humapen savvio pink duration of use were not provided.The device, which was manufactured in august 2014, was not returned to the manufacturer.The initial reporting pharmacist did not relate the event to insulin lispro or the humapen savvio pink.The second reporting pharmacist did not provide a relatedness assessment for the event to insulin lispro or the humapen savvio pink.Update on (b)(6) 2018: information received on (b)(6) 2018 and (b)(6) 2018 were processed together.Update on (b)(6) 2018: additional information received on (b)(6) 2018 from global product complaint database reiterated the lot number 1404v08 for product complaint (b)(4) relating to the humapen savvio (pink) device.Which was already present and correct in the case.Update on (b)(6) 2018: updated medwatch fields for expedited device reporting.No new information added.Edit on (b)(6) 2018: upon internal review of the case, added pc information to the narrative.No other changes were made to the case.Update on (b)(6) 2018: additional information received on (b)(6) 2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1404v08 of a humapen savvio (pink) device.Corresponding fields and narrative updated accordingly.Update on (b)(6) 2018: upon review on (b)(6) 2018, it was determined that case (b)(4) was a duplicate of case (b)(4).All information from case (b)(4) has been captured in this case ((b)(4) and case (b)(4) will be deleted from the database.Edit on (b)(6) 2018: upon internal review on (b)(6) 2018, it was determined source documents from deleted case (b)(4) were missing.The source documents were added.No other change made to case.
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Manufacturer Narrative
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No further follow-up is planned.Evaluation summary: a pharmacist reported on behalf of a female patient that after priming the patient's humapen savvio device, some insulin came out of the needle.The patient experienced increased blood glucose.The device was not returned for investigation (batch 1404v8, manufactured on (b)(6) 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to leaking after injection (or priming) issues or dose accuracy.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.
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Search Alerts/Recalls
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