• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (RED) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9694
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(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, concerns a (b)(6) caucasian female patient. Medical history included hernia on belly; patient did not hear and obesity. Concomitant medications included metformin, losartan potassium, metoprolol succinate, clopidogrel, rosuvastatin, isosorbide mononitrate, clonazepam and an unspecified medication reported as tomalgin, all for unknown indication. The patient received human insulin (rdna origin) nph (humulin n) cartridge, 24 iu, three times per day, subcutaneously, for type 2 diabetes mellitus, beginning on an unknown date. On an unspecified date, unknown time after commencing treatment with human insulin nph via humapen savvio red, patients diabetes and blood pressure were too high and due to this, patient was hospitalized on (b)(6) 2016. Information regarding corrective treatment and outcome was not provided. Patient was discharge from hospital on (b)(6) 2016. On (b)(6) 2016, physician prescribed and patient started using human insulin (rdna origin) regular (humulin r) cartridge, 6iu, three times per day, subcutaneously, for type 2 diabetes mellitus. Also on (b)(6) 2016, it was thought the humapen savvio red (lot 1406v08) was weird because patient did not feel applying the insulin (product complaint (b)(4)). Patient did not receive corrective treatment for drug dose omission but recovered on the same day. Patient reused the needles sporadically. As of 25oct2016, it was provided that patient spent a day in the hospital (not clear if hospitalized) due to unspecified reason and after patient confessed to a nurse that drank a lot of soft drink. It was unknown if patient underwent any laboratory exam. Human insulin nph and human insulin regular treatment continued. Patient was the operator of device and she was trained. The duration of use for this device model and the duration of use for this specific device were 78 days. The complaint was resolved. The device remained in use, and would not be returned. Reporting consumer did not related blood glucose increased and blood pressure high to human insulin nph because patient was stubborn, ate what she wanted and was obese. No other opinion of relatedness was provided. Update 31oct2016: upon review, the case was opened to update the medwatch fields for regulatory reporting, and to add the product complaint number. Update 02nov2016: additional information received on 02nov2016 from global product complaint database updated the lot number from c348039a to 1406v08 for product complaint (b)(4). The product tab for humapen savvio and the narrative were updated.
 
Manufacturer Narrative
No further follow up is planned. Evaluation summary. A female patient reported her humapen savvio device was not releasing insulin. The patient experienced increased blood glucose. The device was not returned to the manufacturer for investigation (batch 1406v08, manufactured june 2014). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. However, the complaint narrative indicates troubleshooting was performed using a new needle, and insulin was released normally. A complaint history review for the batch did not identify any atypical findings with respect to dose accuracy. 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. The user manual instructs to use a new needle for each injection. There is evidence of improper use. The patient sporadically reused needles. Needle reuse may be relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(6). This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint, concerns a (b)(6) caucasian female patient. Medical history included hernia on belly; patient did not hear and obesity. Concomitant medications included metformin, losartan potassium, metoprolol succinate, clopidogrel, rosuvastatin, isosorbide mononitrate, clonazepam and an unspecified medication reported as tomalgin, all for unknown indication. The patient received human insulin (rdna origin) nph (humulin n) cartridge, 24 iu, three times per day, subcutaneously, for type 2 diabetes mellitus, beginning on an unknown date. On an unspecified date, unknown time after commencing treatment with human insulin nph via humapen savvio red, patients diabetes and blood pressure were too high and due to this, patient was hospitalized on (b)(6) 2016. Information regarding corrective treatment and outcome was not provided. Patient was discharge from hospital on (b)(6) 2016. On (b)(6) 2016, physician prescribed and patient started using human insulin (rdna origin) regular (humulin r) cartridge, 6iu, three times per day, subcutaneously, for type 2 diabetes mellitus. Also on (b)(6) 2016, it was thought the humapen savvio red (lot 1406v08) was weird because patient did not feel applying the insulin (product complaint 3813696). Patient did not receive corrective treatment for drug dose omission but recovered on the same day. Patient reused the needles sporadically. As of (b)(6) 2016, it was provided that patient spent a day in the hospital (not clear if hospitalized) due to unspecified reason and after patient confessed to a nurse that drank a lot of soft drink. It was unknown if patient underwent any laboratory exam. Human insulin nph and human insulin regular treatment continued. Patient was the operator of device and she was trained. The duration of use for this device model and the duration of use for this specific device were 78 days. The complaint was resolved. The device was not returned. Reporting consumer did not related blood glucose increased and blood pressure high to human insulin nph because patient was stubborn, ate what she wanted and was obese. No other opinion of relatedness was provided. Update 31oct2016: upon review, the case was opened to update the medwatch fields for regulatory reporting, and to add the product complaint number. Update 02nov2016: additional information received on 02nov2016 from global product complaint database updated the lot number from c348039a to 1406v08 for product complaint 3813696. The product tab for humapen savvio and the narrative were updated update 21nov2016: additional information received on 21nov2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6115693
MDR Text Key60426231
Report Number1819470-2016-00288
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 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9694
Device Lot Number1406V08
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2014
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: 11/19/2016 Patient Sequence Number: 1
Treatment
CLOPIDOGREL; HUMILIN NPH; HUMULIN REGULAR; LOSARTANA POTASSICA; METFORMINA; MONOCORDIL; RIVOTRIL; ROSUVASTATINA; SELOZOK
-
-