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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GREEN) FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GREEN) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9696
Device Problem Device Inoperable (1663)
Patient Problems Hyperglycemia (1905); Shock (2072)
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible. 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 male patient of unknown age and origin. Medical history and concomitant medications were not reported. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) via reusable pen (humapen) (humulin 70/30) subcutaneously. Dosage regimen, indication for use and start date were not provided. On unknown date, while on christmas holiday, the plunger of his humapen was not working and could not be pushed; he could not find a humapen replacement in any pharmacy, so he missed his injection and experienced a hyperglycemic shock (no values provided) (lot number unknown, product complaint number pending). He was taken to the hospital, but it was unknown if he was admitted. The events of hyperglycemia and shock were considered serious due to its medical significance. Information regarding corrective treatments and outcome of the events was not provided. Human insulin isophane suspension 70%/ human insulin 30% was continued. The user of the humapen and their training status was not provided. The humapen model and suspect humapen durations of use were not provided. The humapen was discarded. The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30% or the humapen. Update 17jan2017: upon review, this case was opened to complete the medwatch fields for regulatory reporting.
 
Manufacturer Narrative
Please refer to update statement dated 14feb2017 in describe event or problem. No further follow up is planned. Evaluation summary the son of a male patient reported his father's humapen savvio device "broke. " after inserting a cartridge and dialing the dose, the injection button could not be pushed. The device was not returned to the manufacturer for investigation (batch unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. All humapen savvio 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 spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a male patient of unknown age and origin. Medical history and concomitant medications were not reported. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) via reusable pen (humapen savvio) (humulin 70/30) subcutaneously. Dosage regimen, indication for use and start date were not provided. On unknown date, while on christmas holiday, the plunger of his humapen was not working and could not be pushed; he could not find a humapen replacement in any pharmacy, so he missed his injection and experienced a hyperglycemic shock (no values provided) (lot number unknown, 3875104). He was taken to the hospital, but it was unknown if he was admitted. The events of hyperglycemia and shock were considered serious due to its medical significance. Information regarding corrective treatments and outcome of the events was not provided. Human insulin isophane suspension 70%/ human insulin 30% was continued. The user of the humapen and their training status was not provided. The humapen model and suspect humapen durations of use were not provided. The humapen was discarded, and not returned. The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30% or the humapen. Update 17jan2017: upon review, this case was opened to complete the medwatch fields for regulatory reporting. Edit 30-jan-2017: additional information received from internal communication on 30-jan-2017. Product complaint reference ((b)(4)) number was processed and added to narrative accordingly. Updated unknown humapen suspect device to a humapen savvio green. No other changes were added. Update 14-feb-2017: additional information received on 14-feb-2017 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
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Brand NameHUMAPEN SAVVIO 3ML (GREEN)
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6266699
MDR Text Key65409478
Report Number1819470-2017-00011
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K160668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9696
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/20/2017 Patient Sequence Number: 1
Treatment
HUMULIN
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