Model Number MS9557 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hyperglycemia (1905); Vomiting (2144); Numbness (2415)
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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 report will be submitted when the final evaluation has been completed.
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Event Description
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(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned an approximately (b)(6) female patient of unknown origin.Medical history included hypertension.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% insulin (rdna) (humulin 70/30, cartridge) via a reusable pen (humapen ergoii), 20 iu in the morning and 20 iu in the evening, subcutaneously, for treatment of diabetes, beginning in 2009.Around 2015 or 2016, she was checked out peripheral neuropathy, and she experienced hands and feet numbness.On unspecified date, she was hospitalized due to vomiting and high blood sugar ((b)(4)/ batch: 1010d04).No further information regarding hospitalization was provided.Information regarding corrective treatments and outcome of the events were unknown.Human insulin isophane suspension 70%/human insulin 30% insulin treatment was continued.The patient was the operator of the humapen ergoii and her training status was not provided.The humapen ergoii model duration of use was not provided but started around 2011 or 2012.The action taken with the suspect device and its return status were unknown.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% insulin treatment or not or humapen ergoii.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Edit 31mar2017.Case was opened to enter the medwatch device fields and correct the european/canadian device tab for device mailing.No new information.Update 04-apr-2017: no additional information was received on 01-apr-2017.No changes made in the case.Update 05-apr-2017: information received from the responsible complaint personnel on 29-mar-2017.(b)(4) was received and processed.The suspect device was recoded from humapen unknown type to humapen ergoii.No further changes made in the case.
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Manufacturer Narrative
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New updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.Evaluation summary a doctor reported, on the behalf of a female patient, the cap of the patient's humapen ergo ii device was loose "because the pen had been used for a long time." the patient experienced increased blood glucose.The investigation of the returned device (batch number 1010d04, manufactured october 2010) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The cartridge holder and the pen cap did not snap together firmly.The wear observed on the cartridge holder occurred in the field and not during the manufacturing process.The duration of use was not provided; however, the doctor indicated the use started five (5) to six (6) years ago.The user manual states the humapen ergo ii device has been designed to be used for up to 3 years after first use.There is evidence of improper use.It is possible the patient used the device beyond its approved use life.This may not be relevant to the event of increased blood glucose.
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Event Description
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(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned an approximately (b)(6) female patient of unknown origin.Medical history included hypertension.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% insulin (rdna) (humulin 70/30, cartridge) via a reusable pen (humapen ergo ii), 20 iu in the morning and 20 iu in the evening, subcutaneously, for treatment of diabetes, beginning in 2009.Around 2015 or 2016, she was checked out peripheral neuropathy, and she experienced hands and feet numbness.On unspecified date, she was hospitalized due to vomiting and high blood sugar.No further information regarding hospitalization was provided.The cap of the humapen ergo ii was reportedly loose because the pen had been used for a long time ((b)(4)/ batch: 1010d04).Information regarding corrective treatments and outcome of the events were unknown.Human insulin isophane suspension 70%/human insulin 30% insulin treatment was continued.The patient was the operator of the humapen ergo ii and her training status was not provided.The humapen ergo ii model duration of use was not provided but started around 2011 or 2012.The humapen ergo ii was returned to the manufacturer on 31mar2017.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/human insulin 30% insulin treatment or not or humapen ergoii.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Edit 31mar2017.Case was opened to enter the medwatch device fields and correct the european/canadian device tab for device mailing.No new information.Update 04-apr-2017: no additional information was received on 01-apr-2017.No changes made in the case.Update 05-apr-2017: information received from the responsible complaint personnel on 29-mar-2017.(b)(4) was received and processed.The suspect device was recoded from humapen unknown type to humapen ergoii.No further changes made in the case.Update 15may2017: additional information received on 14may2017 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, improper use and storage from no to yes, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the device.Corresponding fields and narrative updated accordingly.
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Search Alerts/Recalls
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