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

Model Number UNKNOWN

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Cataract (1766)

Event Date 01/31/2014

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: the patient experienced a blood glucose level problem while using a humapen (unknown device).There was no product complaint for the device, and it was not returned for investigation.There was evidence of improper use of the device.It was reported that a needle was installed every two to three days and that the humapen was stored when the needle was unremoved sometimes.The device user manual indicates users are to remove the needle after every use and to not store the pen with the needle attached.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6)-year-old male patient of asian ethnicity.Medical history included unspecified cardiovascular disease, hypertension and family history of diabetes.Concomitant medications included metformin, voglibose for unknown indications and unspecified drugs for cardiovascular and hypertension.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30, 100 iu/ml) cartridge, via reusable pen (humapen; unknown body type), twice daily (12 units in morning and 12 units in night) subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2010.On an unknown date after starting human insulin isophane suspension 70%/human insulin 30% therapy, he had blood glucose level problem (units, values and reference ranges not provided) due to which he was hospitalized in 2014.More information regarding hospitalization was not provided.Upon medical advice he discontinued human insulin isophane suspension 70%/human insulin 30% and changed to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25, 100 iu/ml) cartridge, via reusable pen (humapen ergo ii), twice daily (18 iu in morning and 18 iu in night), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2014.It was noted humapen ergo ii (0803d04) was purchased in 2015.On the night of (b)(6) 2019 and in the morning of (b)(6) 2019, he could not inject insulin as the pen broke out (pc number (b)(4)/ lot number 0803d04).It was noted that a new needle was installed every two to three days and that humapen was stored when needle was unremoved sometimes.Corrective treatment was not provided.On unknown date, he got cataract after the using of insulin (it was unknown if it was related to the first or to the second insulin).Outcome of the events was not provided.Status of human insulin isophane suspension 70%/human insulin 30% therapy after discontinuation was not provided and status of insulin lispro protamine suspension 75%/insulin lispro 25% therapy was ongoing.Follow up would not be possible as reporter did not gave consent to be followed up and treating physician contact details were not provided.The operator of the humapen unknown body type and humapen ergo ii devices was not provided and training status of operator was not provided.The general use of the humapen unknown body type was four years, the general use of the humapen ergo ii was approximately four years.The suspect device duration of use for each of the devices was approximately four years.The action taken and return status with respect to suspect humapen unknown body type and humapen ergo ii devices was not provided.The reporting consumer was unsure whether the events of blood glucose abnormal and cataract were related to human insulin isophane suspension 70%/human insulin 30% therapy or not; and was unsure whether the events of cataract and drug dose omission were related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy or not.The reporting consumer did not provide relatedness assessment between the events of blood glucose abnormal and humapen unknown body type; and did not provide assessment for the event of drug dose omission and humapen ergo ii.Edit 25-jan-2019: upon internal review of information received on 18-jan-2019, the lot number of the suspect humapen ergo with pc (b)(4) was changed in product tab, the narrative was updated with the humapen information in the third pharagraph and the as determined causality was updated upon medical request.Narrative and corresponding fields were updated accordingly.Edit 28-jan-2019: upon internal review of information received on 18-jan-2019, the pc was reprocessed and lot number of the suspect device associated with the pc was updated in narrative to match the lot number of the suspect device in catool.No additional changes were performed.Update 29jan2019: additional information received on 24jan2019 from global product complaint database reiterated the lot number 0803d04 for product complaint (b)(4) relating to the humapen ergo ii device, which was already present and correct in the case.Corresponding fields and narrative updated accordingly.Upon review, improper use and storage details were added to the narrative and suspect device age fields were updated from unknown to four years.Edit 01feb2019: upon internal review of the information, the event of cataract was added in narrative according to the information entered into the case.Upon internal review from the affiliate, the humapen ergo ii unknown lot number was recoded to humapen unknown body type.The eu/(b)(4) fields were updated accordingly.The relatedness assessment for the events and the devices was corrected accordingly.Narrative was updated.Update 06feb2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.Entered a device specific safety summary (dsss) for the humapen (unknown body type).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: 8328756
• MDR Text Key: 136126922
• Report Number: 1819470-2019-00015
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• 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: 01/18/2019
• 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
• Patient Age: 73 YR
• Patient Weight: 80