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

Model Number MS9557

Device Problem High Readings (2459)

Patient Problem Myocardial Infarction (1969)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

This is an initial report.A report will be submitted when the final evaluation has been completed.

Event Description

(b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) male patient of (b)(6) origin.Medical history included myocardial infarction and concomitant medications acarbose for an unknown indication the patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 300u/3ml) from a cartridge via reusable humapen ergo ii, 19 units in morning and 18 units at night subcutaneously for the treatment of diabetes mellitus beginning in 2008.On (b)(6)2017, while on insulin lispro protamine suspension 75%/insulin lispro 25%, his blood glucose was too high and was hospitalized.Further information regarding hospitalization was not reported.Information regarding corrective treatment and outcome of the event was not reported.Insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo ii and his/her training status was not provided.The humapen ergo model duration of use and the suspect humapen ergo ii duration of use were not provided.The suspect humapen ergo ii was continued and it was not returned.The reporting consumer did not know relatedness assessment between the event and insulin lispro protamine suspension 75%/insulin lispro 25%.The reporting consumer did not provide relatedness assessment between the event and humapen ergo ii.Update 08sep2017: updated medwatch fields for expedited device reporting.No new information added.Edit 20-nov-2017: upon review, completed the european and canadian required device reporting elements for suspect device.No other changes were made to the case.

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated (b)(6) 2017 in describe event or problem.No further follow-up is planned.Evaluation summary: a male patient reported that the pen body of his humapen ergo ii device was cracked.The patient experienced increased blood glucose.The investigation of the returned device (batch 0912d02, manufactured december 2009) found that the device met functional requirements and met dose accuracy and glide force specifications.No malfunction was identified.The investigation also found the pen housing and bezel were cracked, and the soft touch was partially detached from the device.The soft touch damage is consistent with the device having been exposed to an unknown chemical while in the field.This damage did not affect the functionality of the device.The user manual describes the proper care and storage of the device and states "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen." in addition, the user manual instructs the patient to not use the device if it appears broken or damaged and to contact lilly or their healthcare provider for a replacement pen.Although the duration of use was not specifically provided by the patient, since the device was manufactured december 2009, it is likely the patient used it beyond its approved use life.The user manual states the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use or storage.The soft touch was damaged due to exposure to an unknown chemical while in the field (not related to the manufacturing process).Since the soft touch does not affect functionality of the device, this is likely not relevant to the increased blood glucose.Additionally, the patient likely used the device beyond its approved use life.Since the device functioned normally and met dose accuracy and glide (injection) force specifications, this is likely not relevant to the event of abnormal blood glucose.

Event Description

(b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6) male patient of manchu origin.Medical history included myocardial infarction and concomitant medications acarbose for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 300u/3ml) from a cartridge via reusable humapen ergo ii, 19 units in morning and 18 units at night subcutaneously for the treatment of diabetes mellitus beginning in 2008.On an unspecified date, the body of the humapen ergo ii device was noted to be cracked (pc (b)(4)/lot 0912d02).On (b)(6) 2017, while on insulin lispro protamine suspension 75%/insulin lispro 25%, his blood glucose was too high and was hospitalized.Further information regarding hospitalization was not reported.Information regarding corrective treatment and outcome of the event was not reported.Insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were not provided.The suspect humapen ergo ii with (b)(4), which was manufactured in dec2009, was returned to the manufacturer on 07nov2017.Upon investigation, it was noted that the device pen housing and bezel were cracked and partially detached from the device which was consistent with an exposure to an unknown chemical while in the field.In addition, it was noted that device was used while damaged and beyond approved use life.The reporting consumer did not know relatedness assessment between the event and insulin lispro protamine suspension 75%/insulin lispro 25%.The reporting consumer did not provide relatedness assessment between the event and humapen ergo ii.Update 08sep2017: updated medwatch fields for expedited device reporting.No new information added.Edit 20-nov-2017: upon review, completed the european and canadian required device reporting elements for suspect device.No other changes were made to the case.Update 11dec2017: additional information received on 11dec2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, improper use and storage from no to yes, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the (b)(4) associated with lot 0912d02 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.

• 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: 7049543
• MDR Text Key: 92725463
• Report Number: 1819470-2017-00204
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0912D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 75