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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Complaint, Ill-Defined (2331)

Event Date 01/31/2010

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2016-00185, since there is more than one device implicated.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a (b)(6) female patient.Medical history included lumbar disc herniation, back pain, bone arthritis, periarthritis of shoulder, spine disease, arteriosclerosis, hypertension, joint pain, could not squad and in the morning her whole body was stiff (relieved after exercise).Concomitant medications included insulin glargine for an unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) form a cartridge via reusable pens (humapen unknown device and from a humapen luxura burgundy), subcutaneously, 12 at morning, 7-8 at noon and 7-8 at evening (no units provided) for the treatment of diabetes mellitus, beginning in 2004.In 2010 she was hospitalized because her blood glucose was not controlled well (no results, baseline results or reference values were provided).In 2011 and 2012 she was hospitalized again due to her blood glucose was not controlled well (no results, baseline results or reference values were provided).No more details regarding admission and discharge dates of the three hospitalizations, as well as treatment and laboratory tests done while hospitalized were provided.In an specific date, the injection pen button of the humapen unknown device could not be pressed ((b)(4), lot number unknown), so she bought a new humapen luxura that also could not be pressed down ((b)(4), lot number 0903b06).In 2012 she was hospitalized due to knee surgery and in 2015 she was hospitalized twice due to high blood pressure.No more details regarding admission and discharge dates of the hospitalizations, as well as treatment and laboratory tests done while hospitalized were provided.It was reported that she increased 9 kg during insulin lispro treatment.She experienced on an unspecified date skin itchiness and had black spot.Information regarding corrective treatments and outcome of the events was not provided.Insulin lispro treatment was ongoing.The user of the humapen luxura and the unknown humapen and her training status was not provided.The general humapen luxura and the unknown humapen, as well as the suspect humapen luxura and the unknown humapen model duration of use were not provided.The suspect humapen unknown device was thrown away; therefore, the device would not be returned.The action taken with the suspect humapen luxura was not reported.The reporting consumer did not know if the events were related to insulin lispro treatment.No assessment of relatedness was made for the reusable pens.Update 12jul2016: upon review, the humapen luxura unknown body type was updated to a humapen luxura burgundy based on the verifiable lot number; added the (b)(4); updated the medwatch fields for regulatory reporting; and updated the narrative.

Manufacturer Narrative

This report is associated with 1819470-2016-00185, since there is more than one device implicated.Evaluation summary: a female patient reported the button of her humapen device could not be pressed down.She experienced abnormal blood glucose levels.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.The exact device model was not reported; however, 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 or storage.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a (b)(6) female patient.Medical history included lumbar disc herniation, back pain, bone arthritis, periarthritis of shoulder, spine disease, arteriosclerosis, hypertension, joint pain, could not squad and in the morning her whole body was stiff (relieved after exercise).Concomitant medications included insulin glargine for an unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) form a cartridge via reusable pens (humapen unknown device and from a humapen luxura burgundy), subcutaneously, 12 at morning, 7-8 at noon and 7-8 at evening (no units provided) for the treatment of diabetes mellitus, beginning in 2004.In 2010 she was hospitalized because her blood glucose was not controlled well (no results, baseline results or reference values were provided).In 2011 and 2012 she was hospitalized again due to her blood glucose was not controlled well (no results, baseline results or reference values were provided).No more details regarding admission and discharge dates of the three hospitalizations, as well as treatment and laboratory tests done while hospitalized were provided.In an specific date, the injection pen button of the humapen unknown device could not be pressed (pc number (b)(4), lot number unknown), so she bought a new humapen luxura that also could not be pressed down (pc number (b)(4), lot number 0903b06).In 2012 she was hospitalized due to knee surgery and in 2015 she was hospitalized twice due to high blood pressure.No more details regarding admission and discharge dates of the hospitalizations, as well as treatment and laboratory tests done while hospitalized were provided.It was reported that she increased 9 kg during insulin lispro treatment.She experienced on an unspecified date skin itchiness and had black spot.Information regarding corrective treatments and outcome of the events was not provided.Insulin lispro treatment was ongoing.The user of the humapen luxura and the unknown humapen and her training status was not provided.The general humapen luxura was approximately 7 years old.The age of the unknown humapen was unknown.The duration of use of each model was not provided.The suspect humapen unknown device was thrown away; therefore, the device would not be returned.The action taken with the suspect humapen luxura was not reported.The reporting consumer did not know if the events were related to insulin lispro treatment.No assessment of relatedness was made for the reusable pens.Update 12jul2016: upon review, the humapen luxura unknown body type was updated to a humapen luxura burgundy based on the verifiable lot number; added the product complaint numbers of (b)(4); updated the medwatch fields for regulatory reporting; and updated the narrative.Update 12-aug-2016: product complaint numbers, already processed, were received on 07-jul-2016.No more changes made in case.Update 18aug2016.Additional information received 17aug2016 from the product complaint safety database.To the hp luxura tab added the manufacture date and approximate device age.To both device tabs added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, 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: 5818893
• MDR Text Key: 50717748
• Report Number: 1819470-2016-00184
• 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,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 65