Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 HP ERGO; 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 HP ERGO; FOR TREATMENT PURPOSES Back to Search Results
Model Number MS8929
Device Problems Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 11/11/2020
Event Type  Injury  
Manufacturer Narrative
Investigation in progress.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2021-00101 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 spontaneous case, reported by a consumer, concerns a (b)(4) female patient with ethnicity reported as han.Medical history included family hereditary diabetes mellitus.Concomitant medication was not provided.The patient received insulin human regular 30% + insulin human nph 70% (origin rdna) (humulin 70/30), from cartridges, 30 units in morning and 27 to 28 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on unknown date in 2000.On an unknown date, patient started using a humapen ergo device and on an unspecified date around 2011, a humapen ergo ii.On unspecified date in 2020, unknown time after starting treatment with insulin human + insulin human nph, the patient was not too normal (as reported), was taken to the hospital for medical advice and the doctors final diagnosis was alzheimers disease, which was considered serious by the company due to its medical significance.It was provided that patient received an unspecified medication for alzheimers disease, but further information was not provided.On an unknown date in 2018 or 2019 (conflicting information received), he had high blood pressure, mild hypertension.On (b)(6) 2020, after commencing treatment with insulin human + insulin human nph, a family member of patient felt speak of patient was not too normal (as reported) , patient was laid in the bed and family member took patient to the hospital, where she was directly rescued and diagnosed with ketoacidosis.The patient was hospitalized for 10 days before discharge.According to physicians advice, on an unknown date in (b)(6) 2020, the patient was changed to use insulin lispro regular 25% + insulin lispro npl 75% (rdna origin) (humalog mix 25) from cartridges, 20 units (specific situation was unknown), at unknown frequency, subcutaneously, on unknown date.On an unknown date, she experienced diabetic complication and itching all over.On unknown date, the injection button of humapen ergo could not be pressed down or pushed (product complaint: (b)(4); lot number: 0404a05) and on unknown exact date, reported as a few days before 23-jul-2021, the injection button of humapen ergo ii was a bit tight and on (b)(6) 2021, operator was not able to press it down (product complaint: 5659348; lot number: 1109d01).It was provided that the needle was not changed each time.She was recovering from hypertension.Information regarding corrective treatment, laboratory exams and outcome of remaining events was not provided.As of (b)(6) 2021, treatment with insulin lispro + insulin lispro npl was ongoing.The operator of the device and training status were not provided.The device model and reported humapen ergo ii had been used for an undisclosed time.The device model humapen ergo ii was used for approximately 10 years and the reported humapen ergo ii had been used for unknown time.Both reported devices were discontinued and returned to the manufacturer for investigation.The reporting consumer did not provide an opinion of relatedness between the events of diabetic complication and itching all over and insulin human + insulin human nph and insulin lispro + insulin lispro npl whereas did not know if events were related to insulin human + insulin human nph and insulin lispro + insulin lispro npl.The reporting consumer did not provide an opinion of relatedness between the events and humapen ergo ii.This case was cross-referenced with case (b)(4) (same patient).Update 04-aug-2021: additional correction of initial information received from affiliate on 23-jul-2021.Added correct event onset date for ketoacidosis.Updated information accordingly.Update 05-aug-2021: additional information received from initial consumer reporter on (b)(6) 2021 in response to medical questionnaire.Added therapies start dates and their dosage regimen, two non serious events of diabetic complication and itching all over, start date of the event of hypertension and cross-referenced case.Updated relatedness status of the event of hypertension with insulin lispro + insulin lispro npl as not associated, severity as mild and outcome as recovering.Updated case and narrative with new information.Edit 12aug2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 13aug2021: upon internal review updated device type from for demonstration purposes to for treatment purposes.
 
Event Description
Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer, concerns a 67-year-old female patient with ethnicity reported as han.Medical history included family hereditary diabetes mellitus.Concomitant medication was not provided.The patient received insulin human regular 30% + insulin human nph 70% (origin rdna) (humulin 70/30), from cartridges, 30 units in morning and 27 to 28 units at night, subcutaneously, for the treatment of diabetes mellitus, beginning on unknown date in 2000.On an unknown date, patient started using a humapen ergo device and on an unspecified date around 2011, a humapen ergo ii.On unspecified date in 2020, unknown time after starting treatment with insulin human + insulin human nph, the patient was not too normal (as reported), was taken to the hospital for medical advice and the doctors final diagnosis was alzheimers disease, which was considered serious by the company due to its medical significance.It was provided that patient received an unspecified medication for alzheimers disease, but further information was not provided.On an unknown date in 2018 or 2019 (conflicting information received), he had high blood pressure, mild hypertension.On (b)(6) 2020, after commencing treatment with insulin human + insulin human nph, a family member of patient felt speak of patient was not too normal (as reported) , patient was laid in the bed and family member took patient to the hospital, where she was directly rescued and diagnosed with ketoacidosis.The patient was hospitalized for 10 days before discharge.According to physicians advice, on an unknown date in (b)(6) 2020, the patient was changed to use insulin lispro regular 25% + insulin lispro npl 75% (rdna origin) (humalog mix 25) from cartridges, 20 units (specific situation was unknown), at unknown frequency, subcutaneously, on unknown date.On an unknown date, she experienced diabetic complication and itching all over.On unknown date, the injection button of humapen ergo could not be pressed down or pushed (product complaint: (b)(4); lot number: 0404a05) and on unknown exact date, reported as a few days before (b)(6) 2021, the injection button of humapen ergo ii was a bit tight and on (b)(6) 2021, operator was not able to press it down (product complaint: (b)(4); lot number: 1109d01).It was provided that the needle was not changed each time.She was recovering from hypertension.Information regarding corrective treatment, laboratory exams and outcome of remaining events was not provided.As of (b)(6) 2021, treatment with insulin lispro + insulin lispro npl was ongoing.The operator of the device and training status were not provided.The device model and reported humapen ergo ii had been used for an undisclosed time.The device model humapen ergo ii was used for approximately 10 years and the reported humapen ergo ii had been used for unknown time.Both reported devices were discontinued and returned to the manufacturer for investigation on (b)(6) 2021.The reporting consumer did not provide an opinion of relatedness between the events of diabetic complication and itching all over and insulin human + insulin human nph and insulin lispro + insulin lispro npl whereas did not know if events were related to insulin human + insulin human nph and insulin lispro + insulin lispro npl.The reporting consumer did not provide an opinion of relatedness between the events and humapen ergo ii.This case was cross-referenced with case (b)(4) (same patient).Update 04-aug-2021: additional correction of initial information received from affiliate on 23-jul-2021.Added correct event onset date for ketoacidosis.Updated information accordingly.Update 05-aug-2021: additional information received from initial consumer reporter on 02-aug-2021 in response to medical questionnaire.Added therapies start dates and their dosage regimen, two non serious events of diabetic complication and itching all over, start date of the event of hypertension and cross-referenced case.Updated relatedness status of the event of hypertension with insulin lispro + insulin lispro npl as not associated, severity as mild and outcome as recovering.Updated case and narrative with new information.Edit 12aug2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 13aug2021: upon internal review updated device type from for demonstration purposes to for treatment purposes.Update 29sep2021: additional information received on 27sep2021 from the global product complaint database.Entered device specific safety summaries (dsss) for pc (b)(4) and pc (b)(4) which were processed together.Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use and storage from no to yes, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer for (b)(4) associated with lot 0404a05 of humapen ergo i device.Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer for (b)(4)associated with lot 1109d01 of humapen ergo ii device.Added date of manufacturer and date returned to manufacturer for the devices.Corresponding fields and narrative updated accordingly.
 
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 29sep2021 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2021-00101 since there is more than one device implicated.Evaluation summary a female patient and her family reported that, on an unknown date, the injection button of the patient's humapen ergo device could not be pressed down.In november 2020, the patient experienced ketoacidosis.The investigation of the returned device (batch 0404a05, manufactured april 2004) found foreign material on multiple internal components of the device, which caused mechanical difficulties that prevented the device from functioning as designed.Malfunction confirmed.The foreign material contamination occurred in the field and was not related to the manufacturing process.The core instructions for use states that the injection button may become harder to push if the inside of the pen gets dirty with insulin, food, drink or other materials.Following the care and storage instructions should help prevent this.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (april 2004), it is likely the patient used it beyond its approved use life.The core instructions for use state the humapen ergo has been designed to be used for up to 3 years after first use.In addition, the patient reported reusing needles.The core instructions for use state to use a new needle for each injection.There is evidence of improper use or storage.The foreign material contamination occurred while in the field (not related to the manufacturing process).The foreign material contamination is likely relevant to the complaint issue.The patient likely used the device beyond the recommended use period and reused needles.It is unknown if these misuses are relevant to the complaint issue or the event of ketoacidosis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HP ERGO
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key12318671
MDR Text Key267277250
Report Number1819470-2021-00102
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K982842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS8929
Device Lot Number0404A05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age67 YR
Patient Weight52
-
-