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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (UNKNOWN COLOR); FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (UNKNOWN COLOR); FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Visual Disturbances (2140)
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned.Evaluation summary the patient experienced blood glucose fluctuations while using a humapen savvio (lot unknown).There was no product complaint for the device and it was not returned for investigation there was evidence of improper use of the device.It was reported that the patient changed the needle of the humapen every week and thus reused needles, and had reduced eyesight.This is likely not relevant given that there was no product complaint relative to pen function.The device user manual indicates a new needle should be used with each injection and that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.
 
Event Description
(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) caucasian female patient.Medical history included diabetes for 20 years, hypertensive and hyperthyroidism.Concomitant medications included three unspecified medications for hypertension, hypothyroidism and cough.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30) via reusable pen (humapen savvio) 38 iu daily, divided on three doses, one with each meal, subcutaneously for the treatment of diabetes mellitus beginning in 2009.Sometime while taking human insulin 70/30, she suffered from her eyes because her sight had been reduced and she also had unspecified problems with her nerves, bones and leg nerves.On an unknown date, she experienced fluctuation in her blood sugar and she suffered from coma every day, because her random blood sugar (rbs) decreased to 20-35-40 mg/dl and sometimes, after that, her rbs was on 400 mg/dl.It was also reported that when she ate sweets and normal food, her blood sugar (bs) remained low, but when she ate only normal food her blood sugar level increased.On an unknown date, her bs was on 270 mg/dl, then she took human insulin 70/30, her bs decreased to 30 mg/dl and she ate something sugary to increase.Her hba1c was on 8-9.On (b)(6) 2016, her fasting blood sugar (fbs) after waking up was on 126 mg/dl and after one hour, it was on 163 mg/dl.The patient was not recovered from the events.Human insulin 70/30 treatment was continued and she was changing the needle of her humapen savvio every week.Information regarding corrective treatment was not provided, but her treating physician advised her to increase her insulin dose if her bs was increased and decrease her insulin dose levels if her bs was decreased.The patient was the operator of the humapen savvio and her training status was not provided.The humapen savvio model duration of use and the suspect device duration of use were not provided.There was no reported complaint for this humapen savvio.The device was not returned.The reporting consumer did not provide an assessment of relatedness between the events and human insulin 70/30 or humapen savvio.Update 01jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 07jul2016: additional information received on 07jul2016 from the global product complaint database added the device specific safety summary; 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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Brand Name
HUMAPEN SAVVIO 3ML (UNKNOWN COLOR)
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5779054
MDR Text Key49133145
Report Number1819470-2016-00167
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 06/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/07/2016
Initial Date FDA Received07/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age40 YR
Patient Weight77
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