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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 Inaccurate Delivery (2339); Difficult to Advance (2920)
Patient Problems High Blood Pressure/ Hypertension (1908); No Code Available (3191)
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 spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) female patient of unknown origin. Medical history included a hospitalization for unspecified reasons. Concomitant medications included acarbose and metformin for unknown indications. The patient received human insulin (rdna origin) injections (humulin 100 u) through cartridges, via reusable humapen ergo ii device, for the treatment of diabetes mellitus. Dosage regimen and start date were not reported. On an unspecified date her blood glucose control was poor (no values reported) and because of it she was hospitalized. While in the hospital her physician switched her to insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50 100 u) through cartridges, via reusable pen (humapen ergo ii), 24 units each morning and 16 units each evening, subcutaneously for the treatment of diabetes mellitus. Start date was not reported. While in the hospital she was diagnosed with high blood pressure and high blood lipids (no values reported for neither). Further details regarding the hospitalization including release date were not reported. On the evening of (b)(6) 2019 she tried injecting 16 units but because the injection button of the humapen ergo ii device could not be pushed down all the way she was only able to get 3 units. On the morning of (b)(6) 2019 she was not able to inject her dose because the injection button of the humapen ergo ii could not be pushed down at all (pc (b)(4), lot 0906d04). Information regarding corrective treatment and outcome of the events was not reported. Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued. The patient was the operator of the humapen ergo ii device and her training status was unknown. The general and suspect humapen ergo ii durations of use were not reported. The suspect humapen ergo ii device associated with pc (b)(4) was returned to the manufacturer on 26feb2019. The reporting consumer did not know if the events were related to human insulin or insulin lispro protamine suspension 50%/ insulin lispro 50%. The reporting consumer related the incorrect dose and the dose omission to the humapen ergo ii device and did not provide an assessment for the remaining events. Update 28feb2019: additional information received on (b)(4) 2019 from global product complaint database. Recoded the suspect humapen luxura, champagne device to a humapen ergo ii device. Updated the lot number from 1201b02 to 0906d04 and the device return status to returned to manufacturer. Added date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4). Corresponding fields and narrative updated accordingly. Edit 06mar2019: 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 Key8426146
MDR Text Key138995253
Report Number1819470-2019-00027
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 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number0906D04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2009
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: 03/15/2019 Patient Sequence Number: 1
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