MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HELF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Break (1069); Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) pediatric male patient of an unknown origin.Medical history was unknown.Concomitant medication included insulin glargine for diabetes.The patient received insulin lispro (rdna origin) (humalog), via a device humapen ergo ii and humapen luxura half dose (hd), subcutaneously for the treatment of diabetes mellitus beginning on unknown date in 2015 (also reported as 2014).Since an unknown date, every time he had insulin lispro injection via humapen ergo ii (full doses) ever since humapen luxura hd was lost (pc number 5779571, lot number 1201g07), he experienced uncontrolled blood sugar and decrease blood glucose level which was 200 mg/dl and 40 mg/dl (reference range not provided).His mother stated that he needed dose correction using half units humapen ergo ii as he was young and whole units are too much for him.On an unknown date, he was administered 1 iu of insulin lispro as a corrective dose and he experienced sever hypoglycemia.It was reported that humapen ergo ii got impaired after 10 days as its screw got stuck (lot number unknown, (b)(4)).He suffered from low blood glucose levels (units, values and reference range was not provided) while taking insulin lispro using humapen ergo.On (b)(6) 2021, as the cartridge holder was broken and displaced from its place, and screw got attached strictly to the humapen.Then he started taking insulin lispro using syringes, but he was suffering from low blood glucose levels and bluish color at site of injection.It was reported that syringes were the worst way to take insulin as it was very painful, and dose cannot be adjusted other than 1 unit.It was also reported that she covered the additional dose with food or honey for him, as in case of taking 1 unit without covering the rest of dose with food he would suffer from low blood glucose levels and blood glucose level reaches 30 mg/dl.The event of second episode of blood glucose decreased was considered as serious by the company due to its medical significance.He had not recovered from the events of injection site bruising, blood glucose increased and first episode of blood glucose decreased and incorrect dose administered.Information regarding the corrective treatment for the events was not provided.Outcome of the remaining events were not provided.Insulin lispro therapy was continued.The operator of the humapen ergo ii and humapen luxura hd was the mother of patient and her training status was not provided.Device duration of use for humapen ergo ii and humapen luxura hd model duration of use was unknown since start date was not provided.Action taken with suspect humapen ergo ii and humapen luxura hd was not provided and their return was expected.The initial reporting consumer did not relate the events blood glucose increased and blood glucose decreased with insulin lispro whereas related the events with humapen ergo ii and humapen luxura hd devices.The reporting consumer related the event blood glucose decreased with the humapen devices.The reporting consumer did not provide a relatedness assessment between the remaining events and insulin lispro therapy or the humapen devices.Update 28-oct-2021: additional information received on 05-oct-2021 from the initial reporter via psp.Added: non-serious event hypoglycemia.Updated patient date of birth.Narrative updated accordingly.Update 11-nov-2021: additional information was received from the initial reporting consumer via the psp on 08-nov-2021.This case was upgraded to serious due to addition of serious event of blood glucose decreased.Added two new non serious events of injection site bruising and incorrect dose administered.Updated device elements, eu(b)(6) fields, device paragraph, causality assessment statement and narrative with new information.Update 08-dec-2021: additional information was received on 05-dec-2021 and 06dec2021 which were processed together.Pc numbers were updated in the narrative.Updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2021-00164 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 6-year-old pediatric male patient of an unknown origin.Medical history was unknown.Concomitant medication included insulin glargine for diabetes.The patient received insulin lispro (rdna origin) (humalog), via a device humapen ergo ii and humapen luxura half dose (hd), subcutaneously for the treatment of diabetes mellitus beginning on unknown date in 2015 (also reported as 2014).Since an unknown date, every time he had insulin lispro injection via humapen ergo ii (full doses) ever since humapen luxura hd was lost (pc number (b)(4)1, lot number 1201g07), he experienced uncontrolled blood sugar and decrease blood glucose level which was 200 mg/dl and 40 mg/dl (reference range not provided).His mother stated that he needed dose correction using half units humapen ergo ii as he was young and whole units are too much for him.On an unknown date, he was administered 1 iu of insulin lispro as a corrective dose and he experienced sever hypoglycemia.It was reported that humapen ergo ii got impaired after 10 days as its screw got stuck (lot number unknown, pc number (b)(4)).He suffered from low blood glucose levels (units, values and reference range was not provided) while taking insulin lispro using humapen ergo.On (b)(6) 2021, as the cartridge holder was broken and displaced from its place, and screw got attached strictly to the humapen.(pc number (b)(4), lot number 1201g07), then he started taking insulin lispro using syringes, but he was suffering from low blood glucose levels and bluish color at site of injection.It was reported that syringes were the worst way to take insulin as it was very painful, and dose cannot be adjusted other than 1 unit.It was also reported that she covered the additional dose with food or honey for him, as in case of taking 1 unit without covering the rest of dose with food he would suffer from low blood glucose levels and blood glucose level reaches 30 mg/dl.The event of second episode of blood glucose decreased was considered as serious by the company due to its medical significance.He had not recovered from the events of injection site bruising, blood glucose increased and first episode of blood glucose decreased and incorrect dose administered.Information regarding the corrective treatment for the events was not provided.Outcome of the remaining events were not provided.Insulin lispro therapy was continued.The operator of the humapen ergo ii and humapen luxura hd was the mother of patient and her training status was not provided.Device duration of use for humapen ergo ii and humapen luxura hd model duration of use was unknown since start date was not provided.Action taken with suspect humapen ergo ii and humapen luxura hd was not provided.The suspect humapen ergo ii (lot number unknown) device associated with product complaint (b)(6) was not returned to the manufacturer.Also, the suspect humapen luxura hd (lot number 1201g07) device associated with product complaint (b)(4) was not returned to the manufacturer.The initial reporting consumer did not relate the events blood glucose increased and blood glucose decreased with insulin lispro whereas related the events with humapen ergo ii and humapen luxura hd devices.The reporting consumer related the event blood glucose decreased with the humapen devices.The reporting consumer did not provide a relatedness assessment between the remaining events and insulin lispro therapy or the humapen devices.Update 28-oct-2021: additional information received on 05-oct-2021 from the initial reporter via psp.Added: non-serious event hypoglycemia.Updated patient date of birth.Narrative updated accordingly.Update 11-nov-2021: additional information was received from the initial reporting consumer via the psp on 08-nov-2021.This case was upgraded to serious due to addition of serious event of blood glucose decreased.Added two new non serious events of injection site bruising and incorrect dose administered.Updated device elements, euca fields, device paragraph, causality assessment statement and narrative with new information.Update 08-dec-2021: additional information was received on 05-dec-2021 and 06dec2021 which were processed together.Pc numbers were updated in the narrative.Updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21dec2021: additional information received on 20dec2021 from the global product complaint database.Entered device specific safety summary (dsss) and updated the medwatch fields/ european and canadian (eu/ca) device information for humapen ergo ii (lot number unknown) associated with product complaint (b)(4) and for humapen luxura hd (lot number 1201g07) device associated with product complaint (b)(4) which were not returned to the manufacturer.The date of manufacturer was updated for humapen luxura hd was updated.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Please refer to update statement dated 21dec2021 in the b.5.Field.This report is associated with 1819470-2021-00164 since there is more than one device implicated.No further follow-up is planned this report is associated with 1819470-2021-00165 since there is more than one device implicated.Evaluation summary the mother of a male patient reported that on (b)(6) 2021, the cartridge holder of her son's humapen luxura hd device "was broken and displaced from its place, and screw got attached strictly to the humapen." she also reported that the device "got heavy to release the dose." on an unknown date, the patient experienced decreased blood glucose.The device was not returned to the manufacturer for investigation (batch number 1201g07, manufactured january 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.A complaint history review did not identify any atypical findings with regard to broken cartridge holder or injection force high issues, and a batch complaint threshold review did not identify any atypical findings with regard to dose accuracy issues.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN LUXURA HELF-DOSE PEN
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical devices manufacturing; 415 red cedar st.; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 12964388
• MDR Text Key: 287256914
• Report Number: 1819470-2021-00165
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Device Lot Number: 1201G07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Sex: Male