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

Model Number UNKNOWN

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.This report is associated with 1819470-2017-00048 and 1819470-2017-00049, since there is more than one device implicated.Evaluation summary: a male patient stated the injection screw of his humapen (unspecified device, obtained in 2013) "could not be moved out" (date unknown).He experienced increased blood glucose levels (date unknown).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.In a related complaint, the patient reported he changed needles every three days.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.The patient used the device for approximately four years.While the device type was unspecified, it is likely a humapen ergo ii based on having received the device in 2013.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.The patient used the device beyond its approved use life.It is unknown if this is relevant to the event of increased blood glucose levels.The patient reused needles which may be relevant to the event of increased blood glucose levels.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unspecified origin.Medical history included that his eyes could not see and hypertension.Concomitant medications included acarbose for an unspecified indication.The patient received human insulin (rdna origin) (unspecified type) subcutaneously via cartridges using an unspecified reusable humapen (reported as lilly pen), two times each day for the treatment of type i diabetes mellitus starting in 1998; dose was not reported.Reportedly he stopped the human insulin in 2010 for unspecified reasons.Since 2010 he received insulin lispro (rdna origin) (humalog 100 u/ml) subcutaneously via cartridges using an unspecified reusable humapen(reported as lilly pen), 16 units each morning and 18 units each evening for the treatment of diabetes mellitus type i.On an unspecified date the humapen injection screw could not be moved out (product complaint (b)(4)/lot unknown).The device was discarded, and he began using another unspecified humapen (reported as lilly pen) in 2013.The second unspecified humapen also has an injection screw that could not be moved out on an unreported date (product complaint (b)(4)/lot unknown).The device was discarded and he began using a reusable pen humapen ergo ii on (b)(6) 2017.On (b)(6) 2017, he reported that the injection button of the humapen ergo ii could not be pushed down (product complaint (b)(4)/lot 1511d03).Reportedly he experienced four cerebral infarctions on unspecified times because his blood glucose was high.Both events were considered serious due to its medical significance.Information regarding corrective treatments and the outcome of the events was not reported.The insulin lispro treatment was continued.The user of the device and his/ her training status was not provided.The general and suspect device duration of use for the unknown humapen associated with product complaint (b)(4) was approximately 15 years; device was discarded.The general and suspect device duration of use for the unknown humapen associated with product complaint (b)(4) was approximately four years; device was discarded.The general and suspect device duration of use for the humapen ergo ii associated with product complaint (b)(4) was 21 days; the device was not returned.The reporting consumer did not know if the events were related to the human insulin or insulin lispro treatments and did not provide an assessment of relatedness regarding to the devices.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 28-feb-2017: upon review of the original source information from (b)(4) 2017, this case was opened to add the product complaint numbers and information to the product tabs and narrative; updated the improper use and storage to yes for the unknown humapen associated with product complaint (b)(4); updated the medwatch and european and canadian required device reporting elements; added the device durations of use; and updated the narrative.Update 02-mar-2017: information received from the rcp on 01-mar-2017.Product complaints (pc) (b)(4) were provided, they would be processed when there were available.Permission to conduct follow-up was retired from the initial reporter on 01-mar-2017.No new adverse event or product information was received.Update 08-mar-2017: additional information received on 08-mar-2017 from the global product complaint database added the device specific safety summary for all three suspect devices; added the manufactured date for the device associated with product complaint (b)(4) and that this device was not returned; updated the improper use and storage to yes for the devices associated with the product complaints (b)(4); updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6395191
• MDR Text Key: 69615062
• Report Number: 1819470-2017-00050
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2017
• 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: ACARBOSE; GLUCOBAY; HUMULIN REGULAR; INSULIN LISPRO
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 65