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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9663
Device Problem Sticking (1597)
Patient Problem No Code Available (3191)
Event Date 02/28/2017
Event Type  Injury  
Event Description
Lilly case id: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and complaint about a product, concerns a female patient of unknown age or ethnicity. Medical history and concomitant medications were not provided. The patient received human insulin (rdna origin) nph (humulin n), cartridge, 16 iu, unknown frequency, route of administration or indication, beginning on an unknown date. The patient also received human insulin (rdna origin) regular (humulin r), unknown dose, frequency, route of administration, indication for use and start date. In (b)(6) 2017, it was not clear if prior or after starting human insulin regular and unknown time after beginning human insulin nph via humapen luxura champagne (lot 1305b09), human insulin nph was not being delivered by the device because the injection screw was not going down and the screw released ((b)(4)/lot 1305b09); the patient was not receiving the medication and felt unwell: the patient became scared, she was hungry, her vision darkened and she fainted. Information regarding corrective treatment was not provided. The patients blood glucose was measured and it ranged between 451, 350, 347 and 500 (units and normal range not provided). Due to these events, the patient was hospitalized (as per follow-up, conflicting information was given by the initial consumer reporter, the patient was not taken to the hospital, so there was no diagnose and laboratory tests). As corrective treatment for blood glucse increased the patient received human insulin nph (unknown formulation) via a syringe and recovered from these events. The patient was discharged from hospital after one week of hospitalization. As of (b)(6) 2017, it was stated that human insulin nph (unknown formulation) was being applied via syringe. On (b)(6) 2017 at night, the human insulin nph (unknown formulation) bottle was over and, on (b)(6) 2017 in the morning, the patient was administered the remained human insulin nph (unknown formulation) from a previous bottle that was opened for more than one month, via a syringe, and the patient had another episode of hyperglycemia. The patient was feeling weakness and, according to a pharmacist, the patient was feeling unwell due to the insulin applied that morning was not recognized by the patient s organism. The patient s blood glucose was measured and it was 340. The patient received human insulin regular (unknown formulation) via a syringe and her blood glucose increased to 390 and after it decreased to 200. On the same date at 7 pm, the patient received human insulin nph (unknown formulation), via a syringe, from a new bottle. On (b)(6) 2017, the patient s blood glucose decreased a lot at 51, but the patient was feeling well. Unspecified time later, the patient s blood glucose normalized. It was reported that the patient s blood glucose fluctuated a lot. The outcome of blood glucose fluctuation was unknown. Information regarding corrective treatment for blood glucose decreased and blood glucose fluctuation was not provided. Treatment with human insulin nph continued. The human insulin regular therapy status was unknown. The patients mother operated the device. It was unknown if she was trained, how long she had used the device model and the reported device lot 1305b09. The complaint was resolved. The device would not be returned. The reporting consumer did not provide an opinion of relatedness between the events and human insulin nph, but considered the event of felt unwell due to was not receiving human insulin nph, which was related to the device complaint. No other opinion of relatedness was provided. Update 15jun2017. Additional information received 13jun2017 from the product complaint safety database. On the device tab entered the manufacture date, changed improper use to yes, entered the device specific safety summary (dsss), updated the european and (b)(6) device information, upda, ted the medwatch field with the device information and the narrative was updated accordingly. Update 08dec2017. Additional information received 07dec2017 from the initial consumer reporter. Added laboratory test; human insulin regular as suspect drug; deleted the event of felt unwell; added serious events of fear, hunger, visual impairment, syncope and hyperglycaemia; non serious events of hyperglycaemia, blood glucose fluctuation, intentional product use issue and blood glucose decreased; conflicting information regarding the hospitalization. Updated corresponding fields and narrative accordingly.
 
Manufacturer Narrative
Device not returned. Usage concerns resolved, and device was reported to be working properly. Narrative field; new updated and corrected information is referenced within the update statements. Please refer to statement dated (b)(6) 2017. Evaluation summary a mother reported on the behalf of a female patient that the injection screw was not going down on her humapen luxura device and insulin was not being released. The device was not returned to the manufacturer for investigation (batch 1305b09, manufactured may 2013). 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. Troubleshooting was performed with guidance of a trained professional. The insulin was then released normally. There is evidence of improper use. The reporter's use issue regarding inability to inject insulin was unspecified. This may be relevant to the complaint.
 
Manufacturer Narrative
Device not returned. Usage concerns resolved, and device was reported to be working properly. New updated and corrected information is referenced within the update statements in describe event or problem. Evaluation summary: a mother reported on the behalf of a female patient that the injection screw was not going down on her humapen luxura device and insulin was not being released. The device was not returned to the manufacturer for investigation (batch 1305b09, manufactured may 2013). 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. Troubleshooting was performed with guidance of a trained professional. The insulin was then released normally. There is evidence of improper use. The reporter's use issue regarding inability to inject insulin was unspecified. This may be relevant to the complaint.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and complaint about a product, concerns a female patient of unknown age or ethnicity. Medical history and concomitant medications were not provided. The patient received human insulin (rdna origin) nph (humulin n), cartridge, 16 iu, unknown frequency, route of administration or indication, beginning on an unknown date. In feb2017, unknown time after beginning human insulin nph via humapen luxura champagne (lot 1305b09), human insulin nph was not being delivered by the device because the injection screw was not going down and the screw released ((b)(4)/lot 1305b09); the patient was not receiving the medication and felt unwell. Due to this, the patient was hospitalized. Additional information regarding corrective treatments, outcomes and exams was not provided. The patient was discharged from hospital after one week of hospitalization. As of (b)(6) 2017, it was stated that human insulin nph (unknown formulation) was being applied via syringe. Treatment with human insulin nph continued. The patients mother operated the device. It was unknown if she was trained, how long she had used the device model and the reported device lot 1305b09. The complaint was resolved. The device would not be returned. The reporting consumer did not provide an opinion of relatedness between the events and human insulin nph, but considered the event of felt unwell due to was not receiving human insulin nph, which was related to the device complaint. No other opinion of relatedness was provided. Update 15jun2017. Additional information received 13jun2017 from the product complaint safety database. On the device tab entered the manufacture date, changed improper use to yes, entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch field with the device information and the narrative was updated accordingly.
 
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Brand NameHUMAPEN LUXURA CHAMPAGNE
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key6679990
MDR Text Key281326658
Report Number1819470-2017-00100
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9663
Device Lot Number1305B09
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/30/2017 Patient Sequence Number: 1
Treatment
HUMULIN N (HUMULIN NPH) CARTRIDGE; HUMULIN N (HUMULIN NPH) CARTRIDGE
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