MAUDE Adverse Event Report: ELI LILLY AND COMPANY HP ERGO; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Material Integrity Problem (2978); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 07/31/2019

Event Type  Injury  

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown origin.Medical history was not provided.Concomitant medication included combination of insulin and isophane insulin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from cartridge via a reusable pen humapen ergo, 30 units unknown frequency subcutaneously for diabetes mellitus, beginning on an unknown date.Also received human insulin (rdna origin) (humulin r) from cartridge, unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.He used same humapen ergo for human insulin and human insulin isophane suspension 70%/human insulin 30% since 2003.Since an unknown date in (b)(6) 2019, while on human insulin isophane suspension 70%/human insulin 30% and human insulin, he got tired as his blood glucose level reached 1000 mg/dl and his blood pressure exceeded 220 mm hg, due to which he was hospitalized on an unknown date in (b)(6) 2019 and got into the icu for seven day.Further details about hospitalization were not provided.Additionally it was reported that he was working in a chocolate factory and he was eating a massive amounts of chocolate that lead his condition to deteriorate.Since an unknown date, he experienced diabetes complications and due to which he suffered from weak nerves and neuropathy, also had been suffering from weak vision and had already under went nine surgeries due to diabetic complications.He had been wearing eye glasses since he was 45 years old.The event of diabetic complications and visual impairment was considered as serious by the company due to medical significance reason.On an unknown date, humapen got impaired and became heavy upon pressing which lead to pain at site of injection, since he had neuropathy he could not press the injection button heavily to release the dose, the pen cap became loose so he had to seal it using a tape ((b)(4) lot 0608a04 as reported).Information regarding corrective treatment was not provided.Outcome of the events fatigue, blood glucose increased and blood pressure increased was resolved while outcome for remaining events was unknown.And human insulin isophane suspension 70%/human insulin 30% therapy status was not provided.The operator of the humapen ergo was patient and his training status was not provided.The general humapen ergo duration of use was 16 years and the suspect humapen ergo duration of use was not provided however started in 2003.Action taken with suspect humapen ergo was not provided and its return was expected.The initial reporting consumer did not provide the opinion of relatedness between the events and human insulin isophane suspension 70%/human insulin 30% and human insulin therapy, while related the event of injection site pain with humapen ergo and did not provide relatedness for remaining events with humapen ergo.Update 02-nov-2021: information received from responsible complaint personnel (rcp) on 29-oct-2021 included only pc number against humapen ergo.No other information received in the case.Edit 16nov2021: 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.

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 09dec2021 in the b.5.Field.No further follow-up is planned.Evaluation summary : a male patient reported that his humapen ergo device "got impaired and became heavy upon pressing which led to pain at site of injection." he reported that due to neuropathy, "he couldn't press the injection button heavily to release the dose." he experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 0608a04, manufactured august 2006).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to high injection force or dose accuracy issues.All humapen ergo devices were assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient reported that he had used the device since 2003 (approximately 18 years).The core instructions for use state the humapen ergo has been designed to be used for up to 3 years after first use.The patient reported visual impairment.The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device beyond the recommended use period and used the device while visually impaired.It is unknown if these misuses are relevant to the complaint and the event of increased blood glucose.

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 58-year-old male patient of unknown origin.Medical history was not provided.Concomitant medication included combination of insulin and isophane insulin for diabetes mellitus.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from cartridge via a reusable pen humapen ergo, teal/clear 30 units unknown frequency subcutaneously for diabetes mellitus, beginning on an unknown date.Also received human insulin (rdna origin) (humulin r) from cartridge, unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.He used same humapen ergo, teal/clear for human insulin and human insulin isophane suspension 70%/human insulin 30% since 2003.Since an unknown date in (b)(6) 2019, while on human insulin isophane suspension 70%/human insulin 30% and human insulin, he got tired as his blood glucose level reached 1000 mg/dl and his blood pressure exceeded 220 mm hg, due to which he was hospitalized on an unknown date in (b)(6) 2019 and got into the icu for seven day.Further details about hospitalization were not provided.Additionally it was reported that he was working in a chocolate factory and he was eating a massive amounts of chocolate that lead his condition to deteriorate.Since an unknown date, he experienced diabetes complications and due to which he suffered from weak nerves and neuropathy, also had been suffering from weak vision and had already under went nine surgeries due to diabetic complications.He had been wearing eye glasses since he was 45 years old.The event of diabetic complications and visual impairment was considered as serious by the company due to medical significance reason.On an unknown date, humapen got impaired and became heavy upon pressing which lead to pain at site of injection, since he had neuropathy he could not press the injection button heavily to release the dose, the pen cap became loose so he had to seal it using a tape (pc 5767802/ lot 0608a04 as reported).Information regarding corrective treatment was not provided.Outcome of the events fatigue, blood glucose increased and blood pressure increased was resolved while outcome for remaining events was unknown.Human insulin isophane suspension 70%/human insulin 30% therapy status was not provided.The operator of the humapen ergo, teal/clear was the patient and his training status was not provided.The general humapen ergo, teal/clear duration of use was not provided and the suspect humapen ergo, teal/clear duration of use was 16 years (conflicting device age noted as reportedly started in 2003 and manufactured date 2006).Action taken with suspect humapen ergo, teal/clear was not provided.The suspect humapen ergo teal/clear device associated with pc 5767802 was not returned to the manufacturer.The initial reporting consumer did not provide the opinion of relatedness between the events and human insulin isophane suspension 70%/human insulin 30% and human insulin therapy, while related the event of injection site pain with humapen ergo, teal/clear and did not provide relatedness for remaining events with humapen ergo, teal/clear.Update 02-nov-2021: information received from responsible complaint personnel (rcp) on 29-oct-2021 included only pc number against humapen ergo.No other information received in the case.Edit 16nov2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 30-nov-2021: upon review of information received on 25-oct-2021, recoded device from humapen ergo, unknown pen body type to humapen ergo cch teal.Updated narrative accordingly.Update 09dec2021: additional information received on 05dec2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added date of manufacture for the suspect humapen ergo teal clear device associated with (b)(4)which did not return to manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HP ERGO
• 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; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12829606
• MDR Text Key: 282275333
• Report Number: 1819470-2021-00155
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K982842
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: 0608A04
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2006
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male