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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9694
Device Problems Break (1069); Mechanical Jam (2983)
Patient Problems Nausea (1970); Pain (1994); Swelling (2091); Diabetic Ketoacidosis (2364); Shaking/Tremors (2515); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. Evaluation summary: a patient reported that his humapen savvio device was jammed and the plunger broke. The patient experienced diabetic ketoacidosis. The dates when the patient experienced the device problem and the date of the adverse event were not specified. In addition, the patient administered insulin using vials and syringes and using another manufacturer's insulin device. Therefore, it is unknown if the humapen savvio was in use when the adverse event occurred. 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
Lilly case id: (b)(6). This report is associated with product compliant: (b)(4). This spontaneous case, reported by a consumer, with additional information from the same consumer via patient support program, who contacted the company with an inquiry, with additional information provided by a second consumer reporter concerns an adult male patient of unknown age and ethnicity, who was born on (b)(6) 1977. Medical history included type 1 diabetes mellitus. Historical drug included unspecified insulin. Concomitant medication: insulin glargine for diabetes. The patient received insulin lispro (humalog) at unknown dose, frequency, route of administration, indication for use, beginning on an unknown date in 2013, but it was unclear which formulation patient began the treatment if it was with cartridge or vial. On an unknown date, patient began to use insulin lispro cartridge formulation. However, since the government only provided insulin lispro (humalog) in vial formulation, the patient had to apply the insulin lispro vials using a syringe. On unspecified dates, while using the vial formulation of insulin lispro via syringe, the patient was experiencing pain at injection site, but no further details regarding corrective treatments and outcome for this event were provided. On an unspecified date, unknown if after or before the beginning of insulin lispro therapy and unknown if while using the vial or the cartridge formulation via humapen unknown device (unknown lot), humapen savvio red (lot unknown) or clickstar, the patient experienced renal failure, arterial hypertension and multiple cardiac episodes (unspecified), all of them highly decompensated, and was also experiencing stress, a lot of swelling of legs, on the back of the knees, his glycaemia was low and his kidneys were only working 40%, which was considered serious due to medically significant reasons by the company. As corrective treatment for glycaemia was low patient drunk a cup of water with some sugar and in five or ten minutes his glycaemia started to raise and patient felt better. As corrective treatment for the swelling of legs, on the back of the knees patient needed to drunk a lot of water. The renal failure was considered as serious due to medically significant reasons by the company. No other information regarding laboratorial examinations, corrective treatments and outcome for these events was provided. At the time of report on (b)(6) 2017, the patient was taking insulin glulisine instead of insulin lispro, because the government did not provide the insulin lispro only the insulin glulisine. It was unknown if the patient would return to insulin lispro or not, because there were times that the government only provided insulin lispro and other times that the only insulin provided was the insulin glulisine. As of (b)(6) 2017, it was reported that, on an unspecified date, the patient was hospitalized due to the renal failure and due to the diabetic ketoacidosis. Additional information regarding corrective treatments and outcomes for these events was not provided. It was not provided if patient was discharged from hospital. It was unknown if insulin lispro therapy was ongoing. On an unknown date, the humapen savvio red (lot unknown / product complaint number 4017400) jammed and the plunger broke, so patient discarded the pen. On (b)(6) 2017, while receiving insulin lispro via clickstar, patients glycaemia was lower, was 85 (no units were provided), patient was not feeling well and was shaking (symptoms), also, patient could not concentrate and was experiencing nausea. It was also provided that when patient glycaemia was 150, 200 (no units were provided) patient felt good. No other information about exams, corrective treatment and outcome was provided. On (b)(6) 2017 insulin lispro therapy was ongoing via clickstar pen. It was unknown who operated the devices humapen unknown device (unknown lot) and humapen savvio red (lot unknown) and if the operator was trained. The duration of use for both devices models and the duration of use for these specific devices were not reported. There was no reported complaint for the device humapen unknown device (unknown lot); therefore it would not be returned. The device humapen savvio red (lot unknown) was discarded; therefore was not returned to the manufacturer. The initial reporting consumer related the stress to social circumstances and the injection site pain to the application using syringe, also related the swelling of legs on the back of the knee to the renal function decreased. No other assessment of relatedness was provided. Update 11may2017: additional information received on 10may2017 from the initial reporting consumer via psp. Added patient support program as reporter; diabetic ketoacidosis as serious event; hospitalized as serious criteria for renal failure; changed concomitant humapen unknown device into suspect device. Narrative and corresponding fields were updated accordingly. Update 06jun2017: additional information received on 02jun2017 from initial consumer reporter and a second consumer reporter via psp. Added a second consumer as reporter. Added unspecified insulin as historical drug. Added diabetes as indication for insulin glargine. Added another humalog cartridge as suspect drug. Added humapen savvio red as suspect device. Added serious event of function kidney decreased, added non serious events of blood glucose decreased with malaise and tremor, blood glucose decreased, swelling of legs, concentration impaired and nausea. Added start date of insulin lispro therapy. Updated therapy status. Added information that patient also received insulin lispro via clickstar. Narrative and corresponding fields were updated accordingly. Edit 16jun2017. Case was opened to enter medwatch device (savvio red) fields for device mailing. No new information. Update 21jun2017: additional information received on 19jun2017 from the global product complaint database. Entered device specific safety summary (dsss) for the device related to product complaint (b)(4). Updated the medwatch fields with device information and the european and (b)(6) device information. Corresponding fields and narrative updated accordingly.
 
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Brand NameHUMAPEN SAVVIO 3ML (RED)
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 Key6671477
MDR Text Key78546061
Report Number1819470-2017-00104
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 company representative,consum
Type of Report Initial
Report Date 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9694
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2017
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: 06/27/2017 Patient Sequence Number: 1
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