MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.Please refer to update statement dated 27nov2018.No further follow-up is planned.This report is associated with 1819470-2018-00198 and 1819470-2018-00199 since there is more than one device implicated.Evaluation summary: a patient reported that the cartridge holder of their humapen (unspecified device type) was broken in 2004.The patient experienced hyperglycemia.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a patient of unknown age, gender and origin.Medical history and concomitant medications were not reported.The patient received insulin lispro (rdna origin) (humalog, specific type unknown) from a cartridge via a reusable humapen (unspecified type) and reusable humapen luxura device (champagne; khaki as reported), for the treatment of diabetes beginning on an unknown date in 2001.Dosage regimen was not provided.The patient also received human insulin isophane suspension (rdna origin) (humulin n) from cartridge device via a reusable humapen (unspecified type) and humapen luxura device (burgundy; amaranth, as reported), for the treatment of diabetes beginning on an unknown date in 2001.On an unknown date, while on being on insulin lispro and human insulin isophane suspension therapy, it was noted that the blood glucose was always high and the blood pressure was high.She was hospitalized to regulate the blood glucose due to hyperglycemia and hypertension (no units, values and reference range was provided).Further information regarding hospitalization and discharge dates were not provided.On an unknown date while being on insulin lispro and human insulin isophane suspension therapy, she had a feeling of pain when injecting the medication.The first pen, humapen (unknown) device was broken in 2004 ((b)(4)/lot number unknown).In (b)(6) 2018, the humapen luxura (burgundy) injection button was difficult to push down ((b)(4)/lot 1010b04).It was noted that no foreign material was in the device, the injection button was pressed in the middle slowly with a thumb, needle was attached and connected to the cartridge well.The needle was single "used" and the pen was stored without needle attached.On an unknown date (b)(6) 2018, the humapen luxura (champagne), its injection button was difficult to push down and the cartridge holder trim ring was broken ((b)(4)/lot 0905b02).It was further noted that no foreign material was in the device, the injection button was pressed in the middle slowly with a thumb, needle was attached and connected to the cartridge well.The needle was single used and the pen was stored without needle attached.Outcome for the events and information regarding the corrective treatment was unknown.Insulin lispro and human insulin isophane suspension therapy was ongoing.The operator of the devices was not provided and his/her training status was unknown.The general model device duration was unknown.The humapen unknown device was purchased on an unknown date in 2001 and was used till an unknown date in 2004; unclear of duration.The humapen luxura (champagne), which was manufactured in may2009, was started on an unknown date and was used until (b)(6) 2018.The humapen luxura (burgundy), which was manufactured in oct2010, was started on an unknown date and was used til an unknown date in (b)(6) 2018.The suspect devices were not returned to the manufacturer.The reporting consumer did not know the relatedness between the events and insulin lispro and human insulin isophane suspension therapy.No relatedness was given between the events and the suspect devices.Update 27nov2018: additional information received on 27nov2018 from the global product complaint database.Recoded the device humapen luxura (unknown body type) to humapen luxura (champagne) associated with (b)(4) and lot 0905b02 and device humapen luxura (unknown body type) to humapen luxura (burgundy) associated with (b)(4) and lot 1010b04.Entered device specific safety summaries (dsss) for (b)(4).Updated the medwatch/european and canadian (eu/ca) device information, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 0905b02 of humapen luxura (champagne) and (b)(4) associated with lot 1010b04 of humapen luxura (burgundy) devices.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• 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: 8110218
• MDR Text Key: 128736350
• Report Number: 1819470-2018-00197
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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