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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 Break (1069)
Patient Problems Hearing Loss (1882); Hyperglycemia (1905); Weakness (2145); Ambulation Difficulties (2544)
Event Date 01/31/2014
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated and corrected information is referenced within the update statements. Please refer to update statement(s) dated 13sep2019. No further follow-up is planned. Evaluation summary: a male patient reported that his humapen ergo ii device was dropped and broken on (b)(6) 2019. In 2014, the patient experienced increased blood glucose. The device was not returned to the manufacturer for investigation (batch number 1309d01, manufactured september 2013). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. However, based on the complaint description, the damage to the device occurred in the field, not related to the manufacturing process. All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. The patient also reported visual impairment. The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it. There is evidence of improper use. The patient used the device while visually impaired. It is unknown if this misuse is relevant to the complaint that the device was dropped and broken or to the event of increased blood glucose.
 
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), with additional information from the second reporter via psp, concerned a (b)(6) chinese male patient. Medical history included hypertension. Previous drug adverse reaction and family drug reaction were none. Concomitant medications were none. The patient received insulin human (humulin, specific type was unknown) from cartridge subcutaneously for diabetes, therapy start date and dosage regimen were not provided, insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog 25) from a cartridge, 30 units in the morning daily subcutaneously for the treatment of diabetes mellitus, beginning in 2014. He also received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog 50) from a cartridge, 8-12 units in the evening daily for the treatment of diabetes mellitus, beginning in 2014; all of them via a reusable devices humapen ergo ii (blue, plastic). In 2014, he was hospitalized due to high blood sugar for many times because the effect of insulin human was not good. Physician changed to use insulin lispro 75/25, the initial dosage was morning 30 units and evening 25 units. In the end of 2014, he was hospitalized again because the effect of insulin lispro 75/25 was not good; the blood sugar could not drop down. The fasting blood glucose was 18-19 and the postprandial blood glucose was 26-26. In the end of 2014, he was hospitalized again during the period of hospitalization, the dosage was up to 70/day but it also did not work. Physician suggested him to use insulin lispro 75/25 in the morning and insulin lispro 50/50 in the evening. The dosage was morning 30 units and evening 8-12 units in the evening. The dosage of insulin lispro 50/50 was not decided by physician, just adjusted to patient blood sugar value. He was hospitalized for half a month. In (b)(6) 2015, he was hospitalized and had peritoneal dialysis. After peritoneal dialysis, the blood sugar dropped down, he was discharged in (b)(6) 2016 or (b)(6) 2016. Before he could not walk and whole body was weakness. By (b)(6) 2016, his eyes could not see clear for half a year and his blood sugar was unstable now (sometimes high and sometimes low). The fasting blood glucose was 7. After using insulin lispro 50/50, the symptom improved. On (b)(6) 2016, the screw rod of the humapen ergo ii could not pull out (product complaint 3641528/lot 1109d03). On an unknown date he experienced deafness. The event of deafness was considered as serious due to medically significant reason. On (b)(6) 2019 his second humapen ergo ii was dropped and broken (pc 4852994/ lot 1309d01). The corrective treatment status was not provided. The outcome of the event of deafness was not recovered, whereas outcome of the remaining events were not provided. Insulin lispro 75/25 and insulin lispro 50/50 therapies were continued. It was unknown if he would re-start human insulin treatment or not. The operator of the humapen ergo ii devices was unknown and her/his training status was not provided. The general duration of use of the humapen ergo ii and the duration of use of the suspect first humapen ergo ii associated with pc 3641528 was one year approximately. The first device was returned on 27-apr-2016, and no malfunction was found. The general model duration of use of the second humapen ergo ii device and the suspect second humapen ergo ii device associated with pc 4852994 duration of use were not reported. The action taken with second humapen ergo ii device, which was manufactured in sep2013, was not returned to the manufacturer. The initial reporting consumer did not provide any relatedness for the event of deafness and human insulin, insulin lispro 75/25 and insulin lispro 50/50 drug whereas did not know if the remaining events were related to human insulin, insulin lispro 75/25 and insulin lispro 50/50 therapies. The second reporting consumer did not know of relatedness assessment between the events of deafness and visual impairment and human insulin, insulin lispro 75/25 and insulin lispro 50/50 therapies whereas did not provide relatedness assessment between the remaining events and human insulin, insulin lispro 75/25 and insulin lispro 50/50 drugs. The initial reporting consumer related the event of lack of drug effect to the first humapen ergo ii device issue whereas did not provide relatedness assessment between the remaining events and humapen ergo ii devices. The second reporting consumer did not provide any opinion on relatedness assessment between the events and humapen ergo ii devices. Update (b)(6) 2016: upon review of the source information from 19-apr-2016, the unknown humapen was updated to a humapen ergo ii based on a verifiable lot number; added the product complaint number (b)(4); and updated the narrative. Update (b)(6) 2016: additional information received on 27-apr-2016 from global product complaint database updated the lot number from 1402d02 to 1109d03 for product complaint (b)(4). The product tab for humapen ergo ii and the narrative were updated. Update (b)(6) 2016. No more additional information was received from the initial reporter on 29-apr-2016. There were no responses to the calling. No changes were made to the case. Update (b)(6) 2016: product complaint numbers were received on 21-apr-2016 (pc 3641530 and pc 3641533). No more changes made in case. Update (b)(6) 2016: additional information received on 13-jun-2016 from the global product complaint database added the device specific safety summary, return date of the device, and manufactured date of the device; updated the malfunction field to no; updated the improper use and storage to yes; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update (b)(6) 2019: additional information was received from the second reporter via psp on (b)(6) 2019. Added second consumer as reporter and new patient support program (psp) as reporter, one serious event of deafness, one new suspect humapen ergo ii device and medical history with hypertension. Updated new dosage regimen with unknown lot number and indication from diabetes to diabetes mellitus for insulin lispro 75/25 and insulin lispro 50/50 therapies and frequency to twice a day for suspect for insulin lispro 75/25 therapy, description as reported for event partial sight with eyesight was not good, product complaint (b)(4) received with lot number was processed accordingly, second consumer relatedness and narrative with new information. Edit (b)(6) 2019: upon review of information received on 23-aug-2019 from the initial reporter, changed causality for lack of drug effect events for the second humapen ergo ii from not associated to device nhcp. Updated eu/ca fields for firs humapen ergo ii device. Update (b)(6) 2019: additional information received on 12sep2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use and storage from no to yes, and device return status to not returned to manufacturer. Added date of manufacturer for pc 4852994 associated with lot 1309d01 of humapen ergo ii device. Corresponding fields and narrative updated accordingly.
 
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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 Key9099382
MDR Text Key163913643
Report Number1819470-2019-00167
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
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9557
Device Lot Number1309D01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2013
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: 09/20/2019 Patient Sequence Number: 1
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