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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Dizziness (2194); Discomfort (2330); Dyskinesia (2363); Loss of consciousness (2418); Sweating (2444); Palpitations (2467); Shaking/Tremors (2515); No Code Available (3191)
Event Date 11/30/2019
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
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This solicited case reported by a consumer via patient support program (psp), concerned a (b)(6)-year-old (at the time of initial report) (b)(6) female patient (with nationality: (b)(6)). Medical history included heart not good, body not good, blood pressure high; her parents, son and daughter had diabetes. Historical medication included metformin for the treatment of diabetes mellitus type ii and she had stomach discomfort after eating it. Concomitant medication included insulin human, insulin human injection/isophane for treatment of diabetes mellitus, acarbose for the treatment of diabetes mellitus type ii and an antihypertensive drug (unknown name) for the treatment of hypertension. The patient received insulin lispro (rdna origin) (humalog, unspecific type, 100u/ml) from cartridge via a reusable humapen (ergo ii, blue), 18 iu at morning and 18. 5 iu at night, two times a day(bid), subcutaneously, for the treatment of diabetes mellitus type ii, beginning on an unknown date(from more than 2 years ago). In addition, she received, insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) unknown formulation, subcutaneously, for the treatment of diabetes mellitus, beginning approximately on an unknown date in jun-2018. Dose and frequency of insulin lispro protamine suspension 75%/insulin lispro 25% therapy was unknown. Sometimes she injected extra units of insulin lispro protamine suspension 75%/insulin lispro 25% therapy (reason unknown). On an unknown date, after 2014, while on insulin lispro therapy, sometimes her blood pressure raised up on four or five o clock in the afternoon in winter. When her blood pressure went high, she took a tablet of unknown antihypertensive drug as a corrective treatment. On an unknown date, she had toothache and face ache. Approximately in (b)(6) 2019, she was hospitalized due to toothache and face ache. On an unknown date, after hospitalization she had trigeminal nerve surgery. After the surgery, she fell unwell about the throat, the voice was uncomfortable, the speech was laborious; half face, tongue and nose were numb; half brain was numb and she was unconscious. It was reported that she did not received any corrective treatment for unconscious. According to her treating physician it was a normal reaction after operation. Her mouth slightly askew/crooked mouth, mouth could not open big and eating was difficult. The events of facial asymmetry, intranasal hypoaesthesia, hypoaesthesia oral, eating disorder, dyskinesia, speech disorder, loss of consciousness, hypoaesthesia, toothache and facial pain were considered serious by the company due to their medical significance. In morning of (b)(6) 2019, her tested blood glucose value was 3. 3 (unit and reference range were not provided) and the hypoglycemia occurred (product complaint: 4750464; lot 1508d01). On an unknown date in (b)(6) 2019, conflicting information received, she had hypoglycemia in nights (the blood sugar value was more than 2, no unit was provided). On an unknown dater in (b)(6) 2019, her face was pale, she had sweating, flustered, uncomfortable and hypoglycemia (the blood sugar value was 2. 2, no unit was provided). The event of hypoglycemia was considered serious by the company due to its medical significance reason. On an unknown date, she had several uncomfortable feelings and her blood sugar values were 3. 8, 3. 9 and 4. 0 (no unit or reference range was provided). On (b)(6) 2019, she experienced dizziness, panic, heart shaking and sweating and she was recovered from these event on the same day. Information regarding any further corrective treatment and outcome of the events was not provided. Insulin lispro and insulin lispro protamine suspension 75%/insulin lispro 25% therapy were ongoing. The patient was the operator of humapen and her training status was not provided. The general humapen model duration of use was not provided. The suspect humapen duration of use was approximately two years (since the suspect device was started in 2017). The action taken with the suspect humapen was unknown and its return was not provided. The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro drug or humapen. However, the reporting consumer thought the elevated blood pressure was related to the weather and her mood undulated/emotion. The reporting consumer did not relate the events of serious and non serious episodes of hypoglycemia with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas did not provide an opinion of relatedness with remaining events. Update on 02-jun-2019: additional information was received from initial reporting consumer via a psp on 24-may-2019 and on 30-may-2019 was processed together. Added: corrective treatment of serious event of unconscious from unknown to no. Updated: as reported verbatim of event facial asymmetry. Narrative was updated with new information accordingly. Update on 30-dec-2019: additional information was received from initial reporting consumer via a psp on 25-dec-2019 and a correction on 25-dec-2019 was processed together. Added blood sugar laboratory values. And one concomitant medication. Added one new suspect drug insulin lispro protamine suspension 75%/insulin lispro 25% and one serious event of hypoglycemia. Updated frequency of non serious event of hypoglycemia as intermittent. Narrative was updated with new information accordingly. Edit on 14-jan-2020: upon review of the information received on 22-may-2019, suspect device age was added in product tab (and narrative) as well as the product complaint and lot number citation was also included in the narrative. No other changes were done into the case. Edit on 14jan2020: updated medwatch fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN ERGO II
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
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key9618223
MDR Text Key189835162
Report Number1819470-2019-00233
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
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1508D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2015
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: 01/22/2020 Patient Sequence Number: 1
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