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

Model Number MS8929

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Coma (2417); Ambulation Difficulties (2544)

Event Date 08/08/2016

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 1819470-2011-00222, since there is more than one device implicated.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from another consumer via psp, concerned a (b)(6) female patient.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension (rdna origin) injections (humulin n 100 u/ml), 10 units each morning, 3 units each afternoon and 4 units at night.She also received human insulin (rdna origin) injections (humulin r 100 u/ml), 4 units before sleep.She received both insulins via cartridge, subcutaneously, for the treatment of diabetes mellitus beginning in 2002.She started to use two reusable pen (humapen ergo teal/clear) in 2003.On (b)(6) 2016, she did not inject her insulin dose because her humapen ergo teal/clear pens could not inject (product complaint (b)(4)/ lot no.40259; product complaint (b)(4)/ lot 40259).Due to that, her blood glucose increased to 25.7 (units not provided) and she had hyperglycemia.She had vomiting, a hyperglycemic coma and she was unable to walk.She went to the hospital for emergency treatment and she received an unspecified transfusion therapy as corrective treatment.The events of hyperglycemic coma and unable to walk were considered to be serious due to medical significance.She was not admitted to the hospital but she lasted 12 hours there.As of (b)(6) 2016 she was recovering from the events.As of (b)(6) 2016 her blood glucose levels were controlled well.Human insulin and human insulin isophane suspension therapy was continued.The user of the humapen ergo teal/clear pens and his/her training status was not provided.The humapen ergo teal/clear pens model duration of use was three years.The suspect humapen ergo teal/clear pens duration of use was three years.The suspect humapen ergo teal/clear pens were returned on (b)(6) 2016.The reporting consumer did not know if the events were related to human insulin or human insulin isophane suspension.The reporting consumer did not provide an assessment of relatedness between the events and humapen ergo teal/clear pens.The second consumer did not provide an assessment of relatedness between the events and human insulin or human insulin isophane suspension or the humapen ergo teal/clear pens.Update 16aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 22-aug-2016: additional information received from a second consumer via psp on 18-aug-2016.Added reporter information.Changed serious event of coma to hyperglycemic coma and changed reported as diagnosis as yes.Removed events of hyperglycemia and vomiting due to diagnosis provided.Updated narrative with new information.Update 29-aug-2016: additional information received from initial reporter via a psp on 25-aug-2016.The reporter did not remember details of corrective treatment.No more information was added to the case.Edit 30-aug-2016: information received from the rcp on 30-aug-2016.Product complaint reference number was processed.Per new information humapen ergo ii was updated to humapen ergo teal/clear.Narrative was updated with new information.Update 01-sep-2016: additional information received on 12-aug-2016 from the global product complaint database added a new suspect humapen ergo suspect device associated with product complaint (b)(4)/ lot 40259; update the improper use and storage to yes, the status of the device; and the european and canadian required device reporting elements for the humapen ergo associated with product complaint (b)(4); added the return date for both devices; and updated the narrative.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 13sep2016 in the field.No further follow up is planned.This report is associated with 1819470-2011-00222, since there is more than one device implicated.Evaluation summary a female patient reported her humapen ergo device did not inject insulin, and she experienced diabetic hyperglycemic coma.Investigation of the returned device (batch (b)(4), manufactured september 2002) found that the device met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient indicated she started using the device in 2003.Therefore, it is likely that the patient used the device beyond its approved use life.The user manual states the humapen ergo device has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient indicated the device was started in 2003; therefore, it is likely the patient used the device beyond its approved use life.The extended use is not relevant to this case as the device met dose accuracy and glide (injection) force specifications.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from another consumer via psp, concerned a (b)(6) female patient.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension (rdna origin) injections (humulin n 100 u/ml), 10 units each morning, 3 units each afternoon and 4 units at night.She also received human insulin (rdna origin) injections (humulin r 100 u/ml), 4 units before sleep.She received both insulins via cartridge, subcutaneously, for the treatment of diabetes mellitus beginning in 2002.She started to use two reusable pen (humapen ergo teal/clear) in 2003.On (b)(6) 2016, she did not inject her insulin dose because her humapen ergo teal/clear pens could not inject ((b)(4)/ lot no.40259; (b)(4)/ lot 40259).Due to that, her blood glucose increased to 25.7 (units not provided) and she had hyperglycemia.She had vomiting, a hyperglycemic coma and she was unable to walk.She went to the hospital for emergency treatment and she received an unspecified transfusion therapy as corrective treatment.The events of hyperglycemic coma and unable to walk were considered to be serious due to medical significance.She was not admitted to the hospital but she lasted 12 hours there.As of (b)(6) 2016 she was recovering from the events.As of (b)(6) 2016 her blood glucose levels were controlled well.Human insulin and human insulin isophane suspension therapy was continued.The user of the humapen ergo teal/clear pens and his/her training status was not provided.The humapen ergo teal/clear pens model duration of use was 13 years.The suspect humapen ergo teal/clear pens duration of use was 13 years.The suspect humapen ergo teal/clear pens were returned on (b)(6) 2016, and no malfunction was found.The reporting consumer did not know if the events were related to human insulin or human insulin isophane suspension.The reporting consumer did not provide an assessment of relatedness between the events and humapen ergo teal/clear pens.The second consumer did not provide an assessment of relatedness between the events and human insulin or human insulin isophane suspension or the humapen ergo teal/clear pens.Update 16aug2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 22-aug-2016: additional information received from a second consumer via psp on (b)(6) 2016.Added reporter information.Changed serious event of coma to hyperglycemic coma and changed reported as diagnosis as yes.Removed events of hyperglycemia and vomiting due to diagnosis provided.Updated narrative with new information.Update 29-aug-2016: additional information received from initial reporter via a psp on (b)(6) 2016.The reporter did not remember details of corrective treatment.No more information was added to the case.Edit 30-aug-2016: information received from the responsible complaint person on (b)(6) 2016.Product complaint reference number was processed.Per new information humapen ergo ii was updated to humapen ergo teal/clear.Narrative was updated with new information.Update 01-sep-2016: additional information received on (b)(6) 2016 from the global product complaint database added a new suspect humapen ergo suspect device associated with (b)(4)/ lot 40259; update the improper use and storage to yes, the status of the device; and the (b)(6) required device reporting elements for the humapen ergo associated with (b)(4); added the return date for both devices; and updated the narrative.Update 09-sep-2016: no additional information received on (b)(6) 2016.No more changes.Update 13-sep-2016: additional information received on (b)(6) 2016 from the global product complaint database added the device specific safety summary and manufactured dates for the devices; updated the duration of use for both devices; updated the malfunction field to no for both devices; updated the medwatch and (b)(6) required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN ERGO II
• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5936227
• MDR Text Key: 54265716
• Report Number: 1819470-2016-00237
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS8929
• Device Lot Number: 40259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2002
• 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
• Treatment: INSULIN HUMAN NPH; INSULIN HUMAN REGULAR
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 42