| Model Number MS9557 |
| Device Problems
Mechanical Problem (1384); Failure to Fire (2610)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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 device case, which does not include an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a patient of unknown gender, age, and ethnicity.The patient was taking insulin lispro via humapen ergo ii for the treatment of an unknown indication.The dose, route, frequency, indication for use, and start date were not provided.It was noted that the current pen was used for 8 years and the needle was on device after injection.On (b)(6) 2021, the daughter of the patient stated that the black stick in the pen became malfunctioned and that it was not proceeded by the pen crashing or falling down.It was noted that there was no swelling.Troubleshooting was performed and the dose knob went to zero, but the device did not give any drug.Bd microfine needle tip was suggested.This device was associated with product complaint (b)(4)/lot number 1501d02.The operator and training status of the user was unknown.The duration of use for the device model was unknown and the suspect pen was used for 8 years.The device was returned on 29jun2021 to the manufacturer and a new device was sent to patient.Edit 23jul2021: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.
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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 10aug2021 in the b.5.Field.No further follow-up is planned evaluation summary a patient's daughter reported the "black stick" in the patient's humapen ergo ii device "became malfunctioned and that it was not proceeded by the pen crashing or falling down." there was no reported adverse event.Initial assessment of the sample associated this complaint with the reportable malfunction of a missing abd clicker, which could lead to an under dose.Investigation of the returned device (batch 1501d02, manufactured january 2015) by the manufacturing site found the abd clicker was present and intact; therefore, the reportable malfunction was not confirmed.In addition, the investigation found foreign material on multiple internal components of the device, which caused no clicks while dialing and dosing the pen and mechanical difficulties which prevented the device from functioning as designed.Malfunction confirmed.The foreign material contamination occurred in the field and was not related to the manufacturing process.The core instructions for use states that the injection button may become harder to push if the inside of the pen gets dirty with insulin, food, drink or other materials.Following the care and storage instructions should help prevent this.The patient reportedly used the device for eight years and left the needle attached after injection.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.The core instructions for use also state to remove the needle after every use and do not store the pen with the needle attached.There is evidence of improper use or storage.The foreign material contamination occurred while in the field (not related to the manufacturing process).The patient used the device beyond the recommended use period and left the needle attached after injection.The foreign material contamination is likely relevant to the complaint issue.
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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 device case, which does not include an adverse event, reported by a consumer who contacted the company with a product complaint, concerns a patient of unknown gender, age, and ethnicity.The patient was taking insulin lispro via humapen ergo ii for the treatment of an unknown indication.The dose, route, frequency, indication for use, and start date were not provided.It was noted that the current pen was used for 8 years and the needle was on device after injection.On (b)(6) 2021 or (b)(6) 2021, the daughter of the patient stated that the black stick in the pen became malfunctioned and that it was not proceeded by the pen crashing or falling down.It was noted that there was no swelling.Troubleshooting was performed and the dose knob went to zero, but the device did not give any drug.Bd microfine needle tip was suggested.This device was associated with product complaint (b)(4) /lot number 1501d02.The operator and training status of the user was unknown.The duration of use for the device model was unknown and the suspect pen was used for 8 years.The device was returned on 29jun2021 to the manufacturer and a new device was sent to patient.Edit 23jul2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 04aug2021: additional information was received from the global product complaint database on 03aug2021 for the (b)(4).As a device specific safety summary was not provided by gps, the malfunction and malfunction type were not updated to no at this time.No new information provided.Update 10aug2021: additional information received on 06aug2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and malfunction from yes/cirm to yes/not cirm.Added date of manufacturer for (b)(4) associated with lot 1501d02 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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