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

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Cataract, Induced (1767); Test Result (2695)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: a female patient reported no insulin flew out of her humapen (unspecified device).The patient experienced abnormal blood glucose.The device was not returned to the manufacturer 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 dose accuracy and device functionality with a high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient.Medical history included hypertension, hyperlipaemia and memory was not good.Concomitant medications included acarbose and linagliptin.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen luxura burgundy and humapen unknown type (unknown lot/product complaint (b)(4)), subcutaneously, two times a day 25 units (morning and evening), for treatment of diabetes mellitus, beginning in 1999.On an unspecified date, while taking human insulin isophane suspension 70%/ human insulin 30%, cataract condition appeared in eye.In 2008, approximately nine year after starting human insulin isophane suspension 70%/ human insulin 30% therapy, he was hospitalized because blood glucose was not controlled well (no values or units provided).He was hospitalized for half a month.Treating physician changed human insulin isophane suspension 70%/ human insulin 30% treatment for insulin as part treatment to adjust blood glucose.Further details regarding hospitalization were not provided.In 2014, he was hospitalized again for an unspecified check and treating physician suggested changing back to human insulin isophane suspension 70%/ human insulin 30% treatment.On (b)(6) 2016, due to breakdown of his humapen luxura burgundy (product complaint, lot 1201b06), his blood glucose was high (no values or units provided).Outcome for the events was unknown.Information regarding additional corrective treatment was not provided.Human insulin isophane suspension 70%/ human insulin 30% treatment status was ongoing.The user of the humapen luxura burgundy was unknown and his/her training status was not provided.The humapen luxura burgundy model duration of use was about 11 years and the suspect humapen luxura burgundy duration of use was about two years.The action taken with the suspect humapen luxura burgundy was unknown and its return status was unknown.The reporting consumer did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30% or humapen luxura burgundy, however assessed the drug dose omission event as related to humapen luxura burgundy breakdown.Update01dec2016.Follow up received 01dec016 from the product complaint safety database.On the device tab entered the device specific safety summary (dsss), entered the european and canadian (eu/ca) device information, entered the european and canadian (eu/ca) device and the narrative was 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6142445
• MDR Text Key: 61398123
• Report Number: 1819470-2016-00301
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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: 11/07/2016
• 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
• Treatment: GLUCOBAY (ACARBOSE); HUMAN INSULIN RDNA 30% REGULAR, 70% NPH) CARTRIDGE; TRAJENTA (LINAGLIPTIN)
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 58