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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 Problems Failure to Prime (1492); Device Inoperable (1663)
Patient Problems Hypersensitivity/Allergic reaction (1907); Urinary Frequency (2275)
Event Date 11/01/2016
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 a patient support program (psp), concerned a (b)(6) caucasian male patient. Medical history included an accident in 2011 and had a joint fracture before insulin usage; he could not move his joint well till (b)(6) 2017 and had some problems in his leg nerves. Concomitant medications included metformin hydrochloride for diabetes mellitus, benfotiamine with cyanocobalamin/ pyridoxine hydrochloride as a vitamin supplementation, atorvastatin calcium for an unknown indication, acetylsalicylic acid for blood coagulation and amlodipine besilate for hypertension. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via humapen ergo ii, two times a day (40 iu before breakfast and 25 iu before dinner), subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2014. Sometime approximately in (b)(6) 2016, while on treatment with human insulin isophane suspension 70%/human insulin 30%, he suffered from hypersensitivity. He had been taking loratadine for hypersensitivity. On (b)(6) 2016 his fasting blood glucose level measurement was (228 mg/dl), two hours post prandial blood glucose level was (261 mg/dl) and glycosylated hemoglobin (hba1c) was 11. 1 (units were not provided), so his health care professional (hcp) added insulin lispro. The event of increased blood glucose was considered serious due to other medical significance. On an unspecified date, he felt his blood glucose level was high (units and values were not provided) as he had excessive urination especially during night so he stop administering both insulins. Since an unspecified date his pen was not working as the pen screw did not work well and was not injecting insulin, he tried priming and the pen was not working (product complaint (b)(4), lot number 1206d0l). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) caucasian male patient. The operator of the humapen ergo ii was patient and his training status was not provided. The humapen ergo ii model duration of use was not provided. The suspect humapen ergo ii duration of use was not reported. The action taken with the humapen savvio was not provided and its return was not expected. The reporting consumer did not provide a relatedness assessment between the events and human insulin isophane suspension 70%/human insulin 30% treatment or humapen ergo ii pen. Update 03mar2017: upon review, the case was opened to update the medwatch fields for regulatory reporting.
 
Manufacturer Narrative
New updated and corrected information is referenced within the update statements in describe event or problem. No further follow up is planned. Evaluation summary a male patient reported his humapen ergo ii device was not working as the pen screw did not work well and was not injecting insulin. The patient experienced increased blood glucose. The device was not returned to the manufacturer for investigation (batch number 1206d01, manufactured june 2012). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review of the batch did not identify any atypical findings with respect to device not working. 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. There is no evidence of improper use or storage.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient. Medical history included an accident in 2011 and had a joint fracture before insulin usage; he could not move his joint well till (b)(6) 2017 and had some problems in his leg nerves. Concomitant medications included metformin hydrochloride for diabetes mellitus, benfotiamine with cyanocobalamin/ pyridoxine hydrochloride as a vitamin supplementation, atorvastatin calcium for an unknown indication, acetylsalicylic acid for blood coagulation and amlodipine besilate for hypertension. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30), from a cartridge, via humapen ergo ii, two times a day (40 iu before breakfast and 25 iu before dinner), subcutaneously for the treatment of diabetes mellitus, beginning in (b)(6) 2014. Sometime approximately in (b)(6) 2016, while on treatment with human insulin isophane suspension 70%/human insulin 30%, he suffered from hypersensitivity. He had been taking loratadine for hypersensitivity. On (b)(6) 2016 his fasting blood glucose level measurement was (228 mg/dl), two hours post prandial blood glucose level was (261 mg/dl) and glycosylated hemoglobin (hba1c) was 11. 1 (units were not provided), so his health care professional (hcp) added insulin lispro. The event of increased blood glucose was considered serious due to other medical significance. On an unspecified date, he felt his blood glucose level was high (units and values were not provided) as he had excessive urination especially during night so he stop administering both insulins. Since an unspecified date his pen was not working as the pen screw did not work well and was not injecting insulin, he tried priming and the pen was not working ((b)(4), lot number 1206d01). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient. The operator of the humapen ergo ii was patient and his training status was not provided. The humapen ergo ii model duration of use was not provided. The suspect humapen ergo ii duration of use was not reported. The action taken with the humapen savvio was not provided. The device was not returned to the manufacturer. The reporting consumer did not provide a relatedness assessment between the events and human insulin isophane suspension 70%/human insulin 30% treatment or humapen ergo ii pen. Update 03mar2017: upon review, the case was opened to update the medwatch fields for regulatory reporting. Update 20mar2017: additional information received on 20mar2017 from global product complaint database. Changed the lot number from 1206d0l to 1206d01 for (b)(4) relating to the humapen ergo ii. Corresponding fields and narrative updated accordingly. Update 27mar2017: additional information received on 27mar2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and canadian (eu/ca) device information. Added date of manufacturer. 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
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6414538
MDR Text Key70297673
Report Number1819470-2017-00056
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 04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9557
Device Lot Number1206D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2012
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: 03/17/2017 Patient Sequence Number: 1
Treatment
ASPOCID; ATOR; GLUCOPHAGE; INSULIN HUMAN; MILGA; NORVASC
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