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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
(b)(4). This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) female patient. Medical history included heart disease, cerebral infarction, cerebral thrombosis, hypertension, family allergic history to penicillin (from her father), the heart was not good, heart failure, eyes blurred, allergies, heart uncomfortable, foot had uncomfortable and her sister had diabetes, she received some unspecified antihypertensive drugs and had allergy, redness of face and uncomfortable and hospitalization due to an unknown reason in (b)(6) 2015. Previous drug adverse reaction and family drug reaction was none. Concomitant medications included repaglinide, for the treatment of diabetes mellitus type two, metformin and glucobay, for the treatment of type 2 diabetes mellitus (when ate too much felt uncomfortable), losartan potassium and hydrochlorothiazide, for the treatment of high blood pressure. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix50 100 u/ml) via cartridge, 30 units in the morning and 30 units at night; twice a daily (dose also reported as 10 units in the morning and 20 units at night), subcutaneously, for the treatment of type two diabetes mellitus, beginning in (b)(6) 2015 (conflicting information; therapy start date also reported as (b)(6) 2016), using humapen ergo ii (reusable device) since an unspecified date, on an unspecified date, as per the guidance of her treating physician, the dose of insulin lispro protamine suspension 50%/insulin lispro 50% therapy was adjusted to 20 units in the morning and 20 units in the night. Since being in insulin lispro protamine suspension 50%/insulin lispro 50% treatment, her blood glucose was not controlled well (no units, values and reference ranges were provided). On an unspecified date in (b)(6) 2017, she was hospitalized to regulate her high blood pressure (no units, values and reference ranges were provided). On an unspecified date, after hospitalization her high blood pressure was recovering. On an unspecified date, she was discharged from the hospital (no further information was provided). On an unspecified date in 2017, she experienced numbness, pain in the toes and pain in the feet and right leg. On an unspecified date in (b)(6) 2017, she hospitalized for treatment. On an unspecified date, she did computerised tomogram (ct) examination and she was diagnosed of fracture of the right leg meniscus and toes (no further information was provided). She felt foot pain was related to the foot neuropathy caused by poor blood glucose control (no units, values and reference ranges were provided). The feet meniscus and toes fractures were relevant to the falling down in 2012 or 2013 (preexisting condition). On (b)(6) 2017, she was hospitalized due to her blood glucose was not controlled well (no units, values and reference ranges were provided) in order to receive an unspecified treatment. On (b)(6) 2017, she felt her blood glucose was controlled and was discharged from the hospital on that same date (her fasting blood glucose value was 7. 5 no units and her postprandial blood glucose value was 11. 5 no units). On unknown date her weight decreased from (b)(6) (no units and reference ranges were provided). Since an unspecified date, she received old beijing ointment (as reported) as a corrective treatment of the pain in the legs. On an unspecified date, she experienced high blood sugar and her fasting blood sugar was as high as 18 point (no further information was provided). On (b)(6) 2017, she was hospitalized due to high blood sugar and her fasting blood sugar was as high as 18 point (no units, values and reference ranges were provided). After being improved her high blood sugar, she was discharged from the hospital on (b)(6) 2017. She thought her blood glucose was high because her diet was not well controlled and it was caused by eating the gui ge hong ointment (as reported). It was reported; the sugar content was relatively high and could regulate the viscera. On an unspecified date in (b)(6) 2017, while on insulin lispro protamine suspension 50%/insulin lispro 50% therapy, every time to eat more every time would occur the symptoms of high blood sugar, whole body uncomfortable and eyes blurred and then after taking her metformin and glucobay she had some improvement. On an unspecified date, during the use of insulin lispro protamine suspension 50%/insulin lispro 50% therapy, she had broken down of two humapen ergo ii (insulin pen) ((b)(4); batch number-unknown). As of (b)(6) 2018, her brain was so poor. It was reported that, she could not remember the name of insulin and she did not know whether associated with infarction (preexisting condition). As of (b)(6) 2018, the event of numbness and pain in the toes had been much better. The information regarding additional corrective treatment was not provided. The outcome of the events diabetes mellitus inadequate control, hypertension, blood glucose increased (serious event) and weight decreased were recovering while the outcome of the remaining events were not provided. Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was continued. The operator of the humapen ergo ii was unknown and his/her training status was not provided. The humapen ergo ii model and suspect humapen ergo ii duration of use were not provided. The action taken with suspect humapen ergo ii was not provided and its returned was expected. The reporting consumer did not provide any opinion of relatedness between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment or humapen ergo ii. The reporting consumer felt foot pain was related to the foot neuropathy caused by poor blood glucose control. The feet meniscus and toes fractures were relevant to the falling down in 2012 or 2013 (preexisting condition). The reporting consumer thought blood glucose was high because diet was not well controlled and it was caused by eating the gui ge hong ointment (the sugar content was relatively high and could regulate the viscera). Update 11-jan-2018: additional information was received on 09-jan-2018, from the initial consumer reporter via psp. The information received on 09-jan-2018 and 16-jan-2018 was processed together. Added: four serious events of hypertension, lower limb fracture, foot fracture and blood glucose increased; five non-serious events of blood glucose abnormal, neuropathy peripheral, general physical health deterioration, cerebral disorder and infarction; cerebral infarction, heart disorder, cardiac failure, vision blurred, hypersensitivity, limb discomfort, familial risk factor and falling down as a medical history; drug hypersensitivity, erythema and discomfort as historical adverse reaction; new dosage regimen of metformin; another indication for use of metformin; acarbose, losartan potassium and hydrochlorothiazide as concomitant medication; four dosage regimen of insulin lispro protamine suspension 50%/insulin lispro 50%; lab tests of ct and high blood pressure. Updated: the onset date of the event diabetes mellitus inadequate control; he weight of the patient; therapy start date of insulin lispro protamine suspension 50%/insulin lispro 50%; the event verbatim of the events weight decreased and diabetes mellitus inadequate control. Changed: the action taken of insulin lispro protamine suspension 50%/insulin lispro 50% to dose decreased from no change. Upon review of information received on 17-jul-2017 changed the reported as diagnosis as yes from no. Accordingly, the narrative was updated with new information. Update 19jan2018: updated medwatch fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN, UNKNOWN DEVICE
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key7213781
MDR Text Key98027681
Report Number1819470-2018-00006
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2018
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 Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1
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