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

Model Number MS9557

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

Patient Problems Hyperglycemia (1905); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements in describe event or problem.No further follow-up is planned.Evaluation summary: a female patient reported the injection button of her humapen ergo ii was difficult to push.She also reported she changed needles every 3-4 times.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 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 device functionality and dose accuracy with high probability.The core user manual instructs to use a new needle for each injection.The patient also reported that she had blurred vision and could not see clearly.The user manual states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient reused needles which may be relevant to the event of increased blood glucose levels.The patient used the device while visually impaired.It is unknown if this is 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 male patient of unknown age and origin.Medical history included gallstone.Previous drug adverse reaction and family drug reaction and concomitant medications were unknown.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25, 100 u/ml), through a cartridge at an unknown dose and frequency, subcutaneously injected via a humapen ergo ii, for the treatment of diabetes mellitus, beginning on an unspecified date in (b)(6) 2016.On an unknown date, humapen ergo ii could not work well, the injection button was difficult to push down ((b)(4), lot number unknown).It was noted the needle was changed every three-four times.On an unknown date, she experienced high blood glucose and was hospitalized.Information regarding hospitalization including start and discharge dates, corrective treatment or diagnostic/laboratory test performed, was not provided.She also had blurred vision and could not see clearly.Information regarding corrective treatment was not provided.Outcome of the events was unknown.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of humapen ergo ii was unknown and his/her training status was not provided.The general humapen ergo ii model duration of use and the suspect humapen ergo ii duration of use were unknown.The suspect humapen ergo ii associated with product (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the events were related with the insulin lispro protamine suspension 75%/insulin lispro 25% treatment or the humapen ergo ii.This case is cross linked with the following case: (b)(4).Edit 30-nov-2017: upon review of information received on 24-nov-2017.The malfunction for the suspect device was updated to be unknown.The last name of the secondary reporter was updated to be humalog cn.The outcome of the events was updated to be unknown in the narrative.No other changes were made to the case.Update 15dec2017: additional information received on 14dec2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Noted device was not returned to the manufacturer for product (b)(4) associated with the humapen ergo ii device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO II
• 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: 7130238
• MDR Text Key: 95323946
• Report Number: 1819470-2017-00218
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• 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
• Patient Outcome(s): Hospitalization