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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 Device Operates Differently Than Expected (2913)
Patient Problems Bronchitis (1752); High Blood Pressure/ Hypertension (1908)
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 spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) asian male patient. Medical history included hypertension, renal disease, bronchitis and cardio-cerebrovascular disease. Concomitant medications included acarbose and gliclazide for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25) formulation: cartridge, via humapen ergo ii, 24 iu (with conflicting information received reported as of 22 iu at morning), and 20 iu at night, subcutaneously, for treatment of diabetes mellitus beginning in (b)(6) 2015. On (b)(6) 2016 he was hospitalized to regulate blood glucose and blood pressure; he was discharged on (b)(6) 2016. On (b)(6) 2016 his humapen ergo ii had a failure (product complaint 3565332/lot 1404d03) and did not injected insulin lispro protamine suspension 75%/insulin lispro 25%. He changed to unspecified oral medicine to decreased blood glucose. No further details were reported. Action taken with insulin lispro protamine suspension 75%/insulin lispro 25% was not reported. It was unknown if the patient was a trained user of the device. The patient had used humapen ergo ii devices for about seven months. It was unknown how long the suspect device was used. Use of the device was discontinued. The reporting consumer did not know if there was relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25%. Update 08-feb-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements; add the product complaint number; and update the narrative.
 
Manufacturer Narrative
(b)(4). No further follow up is planned. Evaluation summary: a male patient reported that his humapen ergo ii device was not delivering insulin. The investigation of the returned device (batch 1404d03, manufactured april 2014) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. There is no evidence of improper use.
 
Event Description
Lilly case id: (b)(6). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) asian male patient. Medical history included hypertension, renal disease, bronchitis and cardio-cerebrovascular disease. Concomitant medications included acarbose and gliclazide for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25) formulation: cartridge, via humapen ergo ii, 24 iu (with conflicting information received reported as of 22 iu at morning), and 20 iu at night, subcutaneously, for treatment of diabetes mellitus beginning in (b)(6) 2015. On (b)(6) 2016 he was hospitalized to regulate blood glucose and blood pressure; he was discharged on (b)(6) 2016. On (b)(6) 2016 his humapen ergo ii had a failure (product complaint (b)(4)/lot 1404d03) and did not injected insulin lispro protamine suspension 75%/insulin lispro 25%. He changed to unspecified oral medicine to decreased blood glucose. No further details were reported. Action taken with insulin lispro protamine suspension 75%/insulin lispro 25% was not reported. It was unknown if the patient was a trained user of the device. The patient had used humapen ergo ii devices for about seven months. It was unknown how long the suspect device was used. The device was returned 01feb2016, and no malfunction was found. The reporting consumer did not know if there was relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25%. Update 08-feb-2016: upon review, this case was opened to update the medwatch and european and (b)(6) required device reporting elements; add the product complaint number; and update the narrative. Edit 23-feb-2016: upon internal review (b)(4) received on 29-jan-2016 was already processed. No other changes performed. Update 29-feb-2016: additional information received on 29-feb-2016 from the global product complaint database added the device specific safety summary, manufactured date, and return date of the device; updated the malfunction to no; updated the medwatch and european and (b)(6) required device reporting elements; and updated the narrative.
 
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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 Key5433406
MDR Text Key38092222
Report Number1819470-2016-00030
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 consumer,foreign
Type of Report Initial,Followup
Report Date 01/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9557
Device Lot Number1404D03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2014
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: 02/12/2016 Patient Sequence Number: 1
Treatment
ACARBOSE
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