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

Model Number MS9557

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Type  Injury  

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 1819470-2018-00141 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This device only spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant (pc), concerned a patient of unknown age, gender and origin.Medical history (comorbidity, allergy history, family history), drug adverse reaction history, family drug adverse reaction and concomitant medication were not provided.The patient received unspecified insulin (eli-lilly) via reusable device (humapen, unknown device and humapen ergo ii), for the treatment of diabetes mellitus, beginning on an unknown date.Dose, frequency and route of administration for unspecified insulin were not provided.On an unknown date, after starting unspecified insulin via humapen (unknown device) and humapen ergo ii, humapen (unknown device) of the patient did not work well after it was used for more than ten years ((b)(4)/ lot number unknown).The dose of humapen ergo ii was inaccurate ((b)(4)/ lot number 1704d02).Also, the patient suffered from hypertension (high blood pressure, values were not provided), hyperglycemia (high blood glucose, values were not provided) and dizziness because of injection pen malfunction.The patient reduced the injection dose according to doctor¿s advice which made the patient have hypoglycemia and the patient was hospitalized due to hypoglycemia.Information regarding corrective treatment, outcome for the events and status of unspecified insulin was not provided.The operator of the humapens and his/ her training status were not provided.The model duration of use and suspect duration of use for humapen (unknown device) was not provided but its was started more than ten years ago.The model duration of use and suspect duration of use for humapen ergo ii was not provided but it was started in (b)(6) 2018.The use of the humapen (unknown device) was discontinued on an unknown date and its return status was not provided.The use of the humapen ergo ii was discontinued in (b)(6) 2018 and its return status was not provided.The reporting consumer did not know if events were related to unspecified insulin.The reporting consumer related the events of high blood pressure, high blood glucose and dizziness to humapen ergo ii and humapen (unknown device).The reporting consumer did not provide a relatedness assessment for the remaining events to humapen (unknown device) and humapen ergo ii.Edit 09aug2018: updated medwatch fields for expedited device reporting.No new information added.Update 16-aug-2018: information received from affiliate on 14-aug-2018 was the phone was ¿hanged up¿.No medically significant information has been received and added to the case.Update 23-aug-2018: information was received from affiliate via psp on 21-aug-2018.Follow up was not possible as reporter ¿hung¿ the phone.No new medically significant information was received and no further changes were done to the case.

Event Description

Lilly case id: (b)(4).This device only spontaneous case, reported by a consumer who contacted the company to report adverse events and product compliant (pc), concerned a patient of unknown age, gender and origin.Medical history (comorbidity, allergy history, family history), drug adverse reaction history, family drug adverse reaction and concomitant medication were not provided.The patient received unspecified insulin (eli-lilly) via a reusable humapen (unknown) device and a humapen ergo ii, for the treatment of diabetes mellitus, beginning on an unknown date.Dose, frequency, and route of administration for unspecified insulin were not provided.On an unknown date, after starting unspecified insulin via a humapen (unknown device), it was noted that the device did not work well as it was used for more than ten years (b)(4).Lot number unknown).On an unknown date in jul2018, a humapen ergo ii was purchased.The dose of humapen ergo ii was inaccurate (b)(4).Lot number 1704d02).On an undisclosed date, the patient suffered from hypertension (high blood pressure, values were not provided), hyperglycemia (high blood glucose, values were not provided) and dizziness due to the pen issue.The patient reduced the injection dose according to doctors advice which made the patient have hypoglycemia and the patient was hospitalized due to hypoglycemia.It was unclear which pen was utilized at the time of these events (humapen unknown device stop date unknown and humapen ergo ii stopped sometime jul2018).Information regarding corrective treatment, outcome for the events and status of unspecified insulin was not provided.The operator of the humapen ergo ii and unknown humpen and his/ her training status were not provided.The model duration of use was unknown and suspect duration of use for humapen (unknown device) was not provided but noted to be used for more than ten years.The model duration of use was unknown and suspect duration of use for humapen ergo ii was approximately within one month (started and stopped in jul-2018).The humapen (unknown device) with (b)(4).Was discontinued on an unknown date and was not returned to the manufacturer.The suspect humapen ergo ii with (b)(4).Which was manufactured apr2017, was returned to the manufacturer on 15aug2018.The reporting consumer did not know if events were related to unspecified insulin.The reporting consumer related the events of high blood pressure, high blood glucose and dizziness to humapen ergo ii and humapen (unknown device).The reporting consumer did not provide a relatedness assessment for the remaining events to humapen (unknown device) and humapen ergo ii.Edit 09aug2018: updated medwatch fields for expedited device reporting.No new information added.Update 16-aug-2018: information received from affiliate on 14-aug-2018 was the phone was hanged up.No medically significant information has been received and added to the case.Update 23-aug-2018: information was received from affiliate via psp on 21-aug-2018.Follow up was not possible as reporter hung the phone.No new medically significant information was received and no further changes were done to the case.Update 12sep2018: additional information received on 12sep2018 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch/european and canadian (eu/ca) device information, returned to manufacturer for (b)(4).And device return status to not returned to manufacturer for (b)(4).Associated with of unknown lot of an unknown humapen device.Updated malfunction from unknown to no for (b)(4).Associated with lot 1704d02 of humapen ergo ii.Added date of manufacturer, date returned to manufacturer for the device for (b)(4).Associated with lot of 1704d02 of a humapen ergo ii.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 dated 12sep2018 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2018-00141 since there is more than one device implicated.Evaluation summary: a consumer reported a patient's humapen ergo ii was inaccurate.The patient experienced hypoglycemia and hyperglycemia.The investigation of the returned device (batch 1704d02, manufactured april 2017) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7843257
• MDR Text Key: 119224225
• Report Number: 1819470-2018-00140
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1704D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSULIN (INSULIN)
• Patient Outcome(s): Hospitalization