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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN SAVVIO 3 ML (RED) FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9694
Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Underdose (2542)
Event Type  Injury  
Manufacturer Narrative
New updated and corrected information is referenced within the update statements in describe event or problem. No further follow up is planned. Evaluation summary: the mother of a female patient reported that her daughter's humapen savvio device was not injecting insulin and "when we apply insulin, the device reaches zero but it is not releasing insulin". The patient uses both humulin n and humulin r (two different insulins) with the same device, switching cartridges. She experienced hyperglycemia. The device was not returned to the manufacturer for investigation (batch 1410v01, manufactured october 2014). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. Troubleshooting of the device was provided by a trained professional by having the reporter dial the device three times to 60 units. Insulin started to be released normally at 58 units of the third attempt. After troubleshooting, the device functioned normally. 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 provides adequate priming instruction, including that a new cartridge may need to be primed several times before you see insulin at the needle tip. Switching cartridges repeatedly using the same device may explain why the patient had to prime three times with 60 units. The amount of priming would depend on where the injection screw was in relation to the plunger. There is evidence of improper use. The patient likely did not prime the device; this may be relevant to the event of hyperglycemia.
 
Event Description
(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) female patient of unknown origin. The patient had no medical history or was receiving any concomitant medications. The patient received human insulin (rdna origin) nph (humulin n), 16iu each morning, 6iu at lunch, and also human insulin (rdna origin) regular (humulin r), 4iu each morning, 4iu at lunch, 4iu at dinner; both cartridge, subcutaneously, unknown indication for use, beginning approximately in feb2017. On an unknown date, unknown time after beginning treatment with human insulin nph and human insulin regular, both via humapen savvio red, the device was not injecting the insulin (lot number 1410v01/(b)(4)). Due to this, on an unknown date, the patient experienced hyperglycemia and on (b)(6) 2017 the patient was hospitalized. It was reported that the patient was hospitalized at intensive care unit (icu). As corrective treatment for this event, the patient received both insulin, recovered from the events and on (b)(6) 2017 the patient was discharged from the hospital. It was also provided that the glycaemia of the patient was controlled; however sometimes the glycaemia went down to 50 (units and reference range not provided). Unspecified exams showed that human insulin nph and regular were not being distributed in the body. Information regarding corrective treatment and outcome for this event was not provided. Moreover, it was also provided that the device was stored in the refrigerator, inside a styrofoam box. As of (b)(6) 2017, it was reported that the device did not work anymore and the patient started receiving human insulin nph and regular via syringe, but she was experiencing a lot of pain due to the application. Additional information regarding corrective treatments and outcome was not provided. Human insulin nph and human insulin regular treatment status was continued via syringe. The patient and her mother were the operators of the device and it was unknown if they were trained. The general device use length was approximately two months. The device was not returned to the manufacturer. The reporting consumer related the hyperglycemia and the drug dose omission to the device issue and not to both insulin. No other opinion of relatedness was provided. Update 12apr2017: additional information received on 11apr2017 from the initial reporting consumer was processed within the initial case. Update 13apr2017: additional information received on 11apr2017 from the initial reporting consumer via psp. Added patients date of birth and onset date of drug dose omission. The case remains non-valid. Update 17may2017: this case was initially determined to be non-valid (dug dose omission and incorrect storage of drug). Additional information received on 16may2017 from initial reporting consumer. Added serious event of hyperglycemia; non-serious event of blood glucose decreased; human insulin nph and human insulin regular dose, route of administration and start date; operators of the device; relatedness opinion for the event of drug dose omission. Narrative and corresponding fields were updated accordingly. Upon internal review, removed non-serious event of incorrect storage of drug. Update 26may2017: additional information received on 24may2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information, the european and canadian (eu/ca) device information. Added date of manufacturer for the device. Corresponding fields and narrative updated accordingly. Update 01jun2017: additional information received on 31may2017 from the initial reporting consumer. Added a lot of pain due to the application as non-serious event; information regarding hospitalization and unspecified exams performed. Update therapies status. Narrative and corresponding fields were updated accordingly.
 
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Brand NameHUMAPEN SAVVIO 3 ML (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 Key6650737
MDR Text Key77874361
Report Number1819470-2017-00096
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 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9694
Device Lot Number1410VO1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2014
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: 06/19/2017 Patient Sequence Number: 1
Treatment
HUMULIN N (CARTRIDGE); HUMULIN R (CARTRIDGE)
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