| Model Number MS9557 |
| Device Problems
Break (1069); Use of Device Problem (1670); Incorrect Or Inadequate Test Results (2456)
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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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(b)(4) this solicited case, reported by a consumer and forwarded by a patient support program, with additional information from the initial reporter via a psp, concerns an approximately (b)(6) han chinese male patient.Medical history included hypertension and diabetes mellitus.The patient was not taking any concomitant medications.The patient received human insulin isophane suspension 70%/ human insulin 30% (humulin 70/30) from a cartridge, 12 dosage forms (df) in the morning and 12 df at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2008.In 2011, due to unknown reason, his dosage regimen was adjusted to 14 morning and 10 night (dose unit unknown) and the patient started using a reusable pen humapen ergo ii to deliver the insulin.Around (b)(6) 2015, time to onset four years, the patient began to experience hyperglycemia; fasting blood glucose was 14 and postprandial blood glucose was 17-20 (units not provided).Generally, the patients controlled blood glucose level was fasting of 8-9 and postprandial of 14-15.The patient did not experience any increased risk of hyperglycemia, including infection gastroenteritis, pancreatitis, physical or emotional stress, nor surgery.It was indicated that the patient believed that the hyperglycemia was due to drinking alcohol, since the patient drank alcohol prior to the event.On (b)(6) 2015 the patient was hospitalized due to hyperglycemia.Treatment included continued use with human insulin isophane suspension 70%/ human insulin 30% for hyperglycemia, an unspecified oral medication for hypertension, and an unspecified infusion for an unknown indication.The patient was hospitalized for 10 days and was recovering after discharge.It was indicated that, since an unknown date, the black screw rod on the patients humapen ergo ii would not be push out (lot number unknown, product (b)(4)).On (b)(6) 2015 the patient received a new humapen ergo ii.Event outcome was recovering.On unspecified date the patient have some issues when operating three unspecified reusable pens, that he acquired from local hospitals.He stopped using his first pen because the screw rod could not be pushed out and then bought a second pen, which was broken and had a broken cartridge holder.In (b)(6) 2015, he acquired a new pen, and on (b)(6) 2015 he found that the screw rod of the injection pen could not be pushed out.Additionally, as reported on (b)(6) 2015, the patient had been hospitalized four times, because his blood glucose levels were sometimes high and sometimes low (blood glucose levels were not reported).Information regarding corrective treatment, hospitalization details and outcome for these events was not provided.Treatment with human insulin isophane suspension 70%/ human insulin 30% was continued.The patient was the user of the devices.The training status was not provided.General device use started in 2008.The duration of use for the suspect devices was unknown.If device are returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer could not offer an opinion of relatedness.Update 17-apr-2015: additional information received 16-apr-2015 from the initial reporting consumer.Added and updated blood glucose values and medical history.Updated event outcome to recovering and causality to unknown.Event details were provided and the narrative was updated with new information.Update 13-may-2015: (b)(4) was received on 12-may-2015.Pc had already been processed.Added pc number to the narrative.Update 14-may-2015: additional information received on 14-may-2015 from the global product complaint database added the device specific safety summary; added that the device was not returned; updated the eu/ca fields; and updated the narrative.Update 13-dec-2015: additional information received from the initial reporter via psp on 13-dec-2015.Birth date was added.Blood glucose high and low was added as laboratory data.Dosage regimen information was updated.Second, third, and fourth suspect devices were added.The serious events of blood glucose sometimes high and blood glucose sometimes low were added.Narrative was updated with new information.Update 18dec2015: upon review of this case, the case was opened top update the medwatch fields on the new suspect devices.
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Manufacturer Narrative
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Device is returned, evaluation will be performed to determine if a malfunction has occurred.Evaluation summary a male patient reported that the injection screw would not move out on his humapen ergo ii device.The patient experienced increased and decreased blood glucose levels.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, which would detect a non-moving injection screw with high probability.There is no evidence of improper use or storage.
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Event Description
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(b)(4) this solicited case, reported by a consumer and forwarded by a patient support program, with additional information from the initial reporter via a psp, concerns an approximately (b)(6) han chinese male patient.Medical history included hypertension, diabetes mellitus with the highest blood glucose level being between 16-17 and his preprandial blood glucose was 13.The patient was not taking any concomitant medications.The patient received human insulin isophane suspension 70%/ human insulin 30% (humulin 70/30) from a cartridge, 12 dosage forms (df) in the morning and 12 df at night, subcutaneously, for the treatment of diabetes mellitus, beginning in 2008.In 2011, due to unknown reason, his dosage regimen was adjusted to 14 morning and 10 night (dose unit unknown) and the patient started using a reusable pen humapen ergo ii to deliver the insulin.Around (b)(6) 2015, time to onset four years, the patient began to experience hyperglycemia; fasting blood glucose was 14 and postprandial blood glucose was 17-20 (units not provided).Generally, he controlled blood glucose level was fasting of 8-9 and postprandial of 14-15.He did not experience any increased risk of hyperglycemia, including infection gastroenteritis, pancreatitis, physical or emotional stress, nor surgery.It was indicated that he believed that the hyperglycemia was due to drinking alcohol, since he drank alcohol prior to the event.On (b)(6) 2015 the patient was hospitalized due to hyperglycemia.Treatment included continued use with human insulin isophane suspension 70%/ human insulin 30% for hyperglycemia, an unspecified oral medication for hypertension, and an unspecified infusion for an unknown indication.The patient was hospitalized for 10 days and was recovering after discharge.It was indicated that, since an unknown date, the black screw rod on the patients humapen ergo ii would not be push out (lot number unknown, (b)(4) lot unknown).On (b)(6) 2015 the patient received a new humapen ergo ii.Event outcome was recovering.On unspecified date the patient have some issues when operating three humapen ego ii reusable pens, that he acquired from local hospitals.He stopped using his first pen because the screw rod could not be pushed out and then bought a second pen, which was broken and had a broken cartridge holder.In (b)(6) 2015, he acquired a new pen, and on (b)(6) 2015 he found that the screw rod of the injection pen could not be pushed out (pc 3529687/lot unknown) (3529688/1404d01) (3551499/lot unknown).Additionally, as reported on (b)(6) 2015, the patient had been hospitalized four times, because his blood glucose levels were sometimes high and sometimes low (blood glucose levels were not reported).Additionally, it was confirmed that patient did not appear hypoglycemic, only experienced hyperglycemia.Information regarding corrective treatment, hospitalization details and outcome for these events was not provided.Treatment with human insulin isophane suspension 70%/ human insulin 30% was continued.The patient was the user of the devices.The training status was not provided.General device use started in 2008.The duration of use for the suspect devices was unknown.The devices associated with 3306437, 3551499, 3529687, and 3529688 were not returned.The reporting consumer did not know if the events were related with human insulin isophane suspension 70%/ human insulin 30%.Update 17-apr-2015: additional information received 16-apr-2015 from the initial reporting consumer.Added and updated blood glucose values and medical history.Updated event outcome to recovering and causality to unknown.Event details were provided and the narrative was updated with new information.Update 13-may-2015: (b)(4) was received on 12-may-2015.Pc had already been processed.Added pc number to the narrative.Update 14-may-2015: additional information received on 14-may-2015 from the global product complaint database added the device specific safety summary; added that the device was not returned; updated the eu/ca fields; and updated the narrative.Update 13-dec-2015: additional information received from the initial reporter via psp on 13-dec-2015.Birth date was added.Blood glucose high and low was added as laboratory data.Dosage regimen information was updated.Second, third, and fourth suspect devices were added.The serious events of blood glucose sometimes high and blood glucose sometimes low were added.Narrative was updated with new information.Update 18-dec-2015: upon review of this case, the case was opened to update the medwatch fields on the new suspect devices.Edit 09-jan-2016: humapens ergo were coded for pcs 3529687 & 3529688.Pcs had already been processed.Added pcs numbers to the narrative.Update 18-jan-2016: additional information was received on 12-jan-2016 from the initial reporter.Added: medical history and lab test.Updated narrative with new information.Update 27-jan-2016: additional information was received on 21-jan-2016 from the initial reporter.Added confirmation about hyperglycemia event, the patient did not experience hypoglycemia.Updated narrative accordingly.Update 28-jan-2016: additional information received on 26-jan-2016 from the global product complaint database added information for two humapen ergo ii devices; for the device associated with (b)(4) the device specific safety summary was added, the device was updated to a humapen ergo ii, and the medwatch and european and canadian required device reporting elements were updated; for the device associated with (b)(4) the device specific safety summary and manufactured date were added, and the medwatch and european and canadian required device reporting elements were updated; and the narrative was updated.Update 29-jan-2016: additional information received on 29-jan-2016 from the global product complaint database added the device specific safety summary associated with the (b)(4); added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
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Search Alerts/Recalls
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