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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event, concerned a (b)(6) female patient of unknown origin.Medical history included heart disease, hypertension, asthma and she had allergic constitution (allergic to many drugs).Concomitant medications included an unspecific anti-diabetic capsule and acarbose for unknown indication.The patient received an unspecified form of human insulin (rdna origin) injections (humulin 100 u/ml) from a cartridge, via reusable pen (humapen ergo ii) morning 26iu, noon 22iu, evening 24iu daily, subcutaneously for the treatment of diabetes, beginning approximately in 2009.She also received an unspecified form of human insulin (rdna origin) injections (humulin 100 u/ml) a cartridge, via reusable pen (humapen ergo ii), 14iu before sleep daily, subcutaneously for the treatment of diabetes, beginning approximately in 2009.Injection button of a humapen ergo ii (lot unknown/(b)(4)) moved down automatically like it slides once pressed and without making clicking sounds recently (specific date was unknown).After 9 months (unspecific month) of started both unspecified human insulins, she was hospitalized due to unspecific heart disease and lung infection.More information about this hospitalization was not provided.In addition, since unknown date, she was hospitalized many times due to her problem of allergic constitution, once she needed to change an unspecific drug.Further information regarding this hospitalization was not reported.Next, in (b)(6) 2016, she was hospitalized for treatment due to heart disease, high blood sugar and hypertension.She was discharged from hospital recently on unknown date.Additional details for this hospitalization were not reported.Information regarding corrective treatments and outcome of the events were not provided.Unspecified human insulins were continued.The user of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model duration of use and suspect device duration of use were not provided but started since 2015.Action taken and returned status for suspect humapen ergo ii were not reported.The reporting consumer did not know if the events were related to unspecified human insulins or the humapen ergo ii.Edit 02sep2016.Case was opened to enter medwatch device fields and the european/canadian device fields for device mailing.No new information.Edit 06sep2016.Added the pc number and device complaint information to the narrative.Removed apostrophes from the narrative.Update 12-sep-2016: information from rcp arrived on 26-aug-2016.Pc number was already processed.No other changes were performed.

Manufacturer Narrative

Narrative - new, updated and corrected information is referenced within the update statements in narrative.Please refer to update statement dated 23sep2016 in the narrative.No further follow up is planned evaluation summary a female patient reported the injection button of her humapen ergo ii device moved up and down automatically; it "slides" when pressed.No clicking sounds were heard.The patient experienced increased 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.All humapen ergo ii 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 spontaneous case, reported by a consumer, who contacted the company to report an adverse event, concerned a (b)(6) female patient of unknown origin.Medical history included heart disease, hypertension, asthma and she had allergic constitution (allergic to many drugs).Concomitant medications included an unspecific anti-diabetic capsule and acarbose for unknown indication.The patient received an unspecified form of human insulin (rdna origin) injections (humulin 100 u/ml) from a cartridge, via reusable pen (humapen ergo ii) morning 26iu, noon 22iu, evening 24iu daily, subcutaneously for the treatment of diabetes, beginning approximately in 2009.She also received an unspecified form of human insulin (rdna origin) injections (humulin 100 u/ml) a cartridge, via reusable pen (humapen ergo ii), 14iu before sleep daily, subcutaneously for the treatment of diabetes, beginning approximately in 2009.Injection button of a humapen ergo ii (lot unknown/(b)(4)) moved down automatically like it slides once pressed and without making clicking sounds recently (specific date was unknown).After 9 months (unspecific month) of started both unspecified human insulins, she was hospitalized due to unspecific heart disease and lung infection.More information about this hospitalization was not provided.In addition, since unknown date, she was hospitalized many times due to her problem of allergic constitution, once she needed to change an unspecific drug.Further information regarding this hospitalization was not reported.Next, in (b)(6) 2016, she was hospitalized for treatment due to heart disease, high blood sugar and hypertension.She was discharged from hospital recently on unknown date.Additional details for this hospitalization were not reported.Information regarding corrective treatments and outcome of the events were not provided.Unspecified human insulins were continued.The user of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model duration of use and suspect device duration of use were not provided but started since 2015.The humapen ergo ii was not returned.The reporting consumer did not know if the events were related to unspecified human insulins or the humapen ergo ii.Edit 02sep2016.Case was opened to enter medwatch device fields and the european/canadian device fields for device mailing.No new information.Edit 06sep2016.Added the pc number and device complaint information to the narrative.Removed apostrophes from the narrative.Update 12-sep-2016: information from the complaint department arrived on 26-aug-2016.Pc number was already processed.No other changes were performed.Update 23sep2016: additional information received on 23sep2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN ERGO II/UNKNOWN CH TYPE
• 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: 5955519
• MDR Text Key: 54894268
• Report Number: 1819470-2016-00234
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2016
• 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; HUMULIN NPH; HUMULIN REGULAR
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 64