MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO TEAL/CLEAR; FOR TREATMENT PURPOSES

Model Number MS8929

Device Problem Mechanical Problem (1384)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

(b)(4).This solicited case, reported by a consumer who contacted the company via a patient support program to report an adverse event, concerns a (b)(6) male patient.Medical history included varicose vein and a hospitalization for an unknown reason.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human regular insulin 30% (humulin 70/30, unknown formulation) 13 units each morning and 12 units each evening via a reusable humapen ergo i (teal/clear) device for the treatment of diabetes mellitus, beginning in 2008 during a hospitalization for an unknown reason.On an unknown date, soon after being discharged, the patient experienced hypoglycemia when the initial dosage was injected.Blood glucose was around 3.1 (units not provided).The patient decreased the morning and evening dosage one to two units in response to the event and the hypoglycemia did not reoccur and the blood glucose was stable.The patient continued to decrease the morning and evening dosage five to six units.In (b)(6) 2014, approximately six years after treatment began, the patient was hospitalized because postprandial blood glucose was high.The resident physician changed dosage to 11 units each morning and 10 units each evening.Reportedly, when the patient ate more and did not exercise postprandial glucose would be high.Additional information and corrective treatments were not provided.The patient was discharged from the hospital a half month later.At the end of (b)(6) 2015, the injection pen screw rod on the humapen ergo i (teal/clear) (product complaint: (b)(4) / lot number 0605a04) could not be pushed back, so the patient bought a new humapen ergo ii (royal/royal blue) to inject (lot number 1404d03).Event outcome(s): postprandial blood glucose was high (not recovered), postprandial blood glucose would be high (not recovered), and hypoglycemia (recovering).Treatment with human insulin isophane suspension 70%/ human regular insulin 30% continued.This case included suspect humapen ergo i (teal/clear) device.The patient was the operator of the device and it was unknown if he was a trained user.The general and suspect device duration of use for the humapen ergo i (teal/clear) was approximately seven years.It was unknown if the humapen ergo i (teal/clear) was available to be returned.The consumer reporter related the event of hypoglycemia to human insulin isophane suspension 70%/ human regular insulin 30%.The consumer did not relate the events of high postprandial glucose to human insulin isophane suspension 70%/ human regular insulin 30%.Update 10jul2015: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 21jul2015: upon internal review of the initial source information received on 08jul2015, the following information was updated: improper use/storage field from no to yes for suspect humapen ergo i device and device paragraph.Removed suspect device, humapen ergo ii, as no adverse events occurred with this device.Update 21jul2015: additional information was received on 15jul2015 from the responsible complaint personnel.Processed product complaint (b)(4), as appropriate.Updated: suspect reusable device from humapen ergo (unknown body type) to humapen ergo (teal/clear); device available for evaluation from no to yes; and device preliminary comments to investigation in progress.Narrative updated with the new information.

Manufacturer Narrative

Investigation in progress.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement.No further follow up is planned.Evaluation summary a male patient reported that the injection screw of his humapen ergo device could not be pushed back and he was unable to insert a cartridge.He experienced blood glucose increases and hypoglycemia.Investigation of the returned device (batch (b)(4), manufactured may 2006) found damage to the device, leading to injection screw lockup, consistent with a one-time excessive force applied while in the field.In addition, the device was beyond usable life.The patient reported using the device for approximately seven years.The humapen ergo user manual states the device was designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond its approved use life and applied excessive force causing damage to the device.This may be relevant to the complaint which led to increased blood glucose levels.

Event Description

(b)(4) this solicited case, reported by a consumer who contacted the company via a patient support program to report an adverse event, concerns a (b)(6) chinese male patient.Medical history included varicose vein and a hospitalization for an unknown reason.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human regular insulin 30% (humulin 70/30, unknown formulation) 13 units each morning and 12 units each evening via a reusable humapen ergo i (teal/clear) device for the treatment of diabetes mellitus, beginning in 2008 during a hospitalization for an unknown reason.On an unknown date, soon after being discharged, the patient experienced hypoglycemia when the initial dosage was injected.Blood glucose was around 3.1 (units not provided).The patient decreased the morning and evening dosage one to two units in response to the event and the hypoglycemia did not reoccur and the blood glucose was stable.The patient continued to decrease the morning and evening dosage five to six units.In (b)(6) 2014, approximately six years after treatment began, the patient was hospitalized because postprandial blood glucose was high.The resident physician changed dosage to 11 units each morning and 10 units each evening.Reportedly, when the patient ate more and did not exercise postprandial glucose would be high.Additional information and corrective treatments were not provided.The patient was discharged from the hospital a half month later.At the end of (b)(6) 2015, the injection pen screw rod on the humapen ergo i (teal/clear) (product complaint: 3380290 / lot number 0605a04) could not be pushed back, so the patient bought a new humapen ergo ii (royal/royal blue) to inject (lot number 1404d03).Event outcome(s): postprandial blood glucose was high (not recovered), postprandial blood glucose would be high (not recovered), and hypoglycemia (recovering).Treatment with human insulin isophane suspension 70%/ human regular insulin 30% continued.This case included suspect humapen ergo i (teal/clear) device.The patient was the operator of the device and it was unknown if he was a trained user.The general and suspect device duration of use for the humapen ergo i (teal/clear) was approximately seven years.The device was returned on 15jul20105.The consumer reporter related the event of hypoglycemia to human insulin isophane suspension 70%/ human regular insulin 30%.The consumer did not relate the events of high postprandial glucose to human insulin isophane suspension 70%/ human regular insulin 30%.Update 10jul2015: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 21jul2015: upon internal review of the initial source information received on 08jul2015, the following information was updated: improper use/storage field from no to yes for suspect humapen ergo i device and device paragraph.Removed suspect device, humapen ergo ii, as no adverse events occurred with this device.Update 21jul2015: additional information was received on 15jul2015 from the responsible complaint personnel.Processed product (b)(4), as appropriate.Updated: suspect reusable device from humapen ergo (unknown body type) to humapen ergo (teal/clear); device available for evaluation from no to yes; and device preliminary comments to investigation in progress.Narrative updated with the new information.Update 11sep2015: additional information received on 11sep2015 from the global product complaint database added the device specific safety summary, the return date of the device, and the manufactured date of the device; updated the malfunction field to yes/no cirm; updated the eu/ca and medwatch fields; and updated the narrative.

• Brand Name: HUMAPEN ERGO TEAL/CLEAR
• 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: 4946036
• MDR Text Key: 15914946
• Report Number: 1819470-2015-00069
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS8929
• Device Lot Number: 0605A04
• Other Device ID Number: 3380290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2006
• 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: 55 YR