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Model Number MS9557
Device Problems Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated, and corrected information is referenced within the update statements. Please refer to update statement(s) dated 04may2021. No further follow-up is planned. Evaluation summary female patient reported on unknown date in 2015, her humapen ergo ii device did not work well (specific malfunction unknown). She experienced increased blood glucose. She continued to use device. She reported on unknown date 2021, it was difficult to push down the injection button, the pen leaked after injection, and she suspected the dose was increased since a bottle of insulin was used for 16 days, but now it was used up in 15 days. Device was not returned to the manufacturer for investigation (batch 1112d01, manufactured december 2011). It could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. Complaint history review and batch trend review did not identify any atypical findings with regard to device not working, leaking after injection from device, or dose accuracy issues. All humapen ergo ii devices are assessed for injection screw travel at end of manufacturing process, ensuring device functionality and dose accuracy with high probability. She used device since 2013 (eight years). Core instructions for use state humapen ergo ii has been designed to be used for up to 3 years after first use. Patient continued to use device after experiencing initial complaint issue. Core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use, and always carry spare insulin pen in case your pen is lost or damaged. Patient reported visual impairment. Core instructions state device is not recommended for visually impaired without assistance of sighted individual trained to use it. There is evidence of improper use. Patient continued to use device after experiencing the initial alleged complaint issue. It is unknown if misuse is relevant to the complaint or event of increased blood glucose. Patient used device while visually impaired and used device beyond its recommended use period. It is unknown if these misuses are relevant to the injection difficulty and dose accuracy.
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint, concerned an asian (b)(6) year old female patient. Medical history included hospitalization in 2013, heart was not good and kidney was not good. Concomitant medications included acarbose for unknown indication. The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog 50) from cartridge via reusable pen device (humapen ergo ii) for the treatment of diabetes mellitus, 17 units every morning, subcutaneously beginning on an unknown date in 2013. On an unknown date in 2015 after starting human insulin therapy, she was hospitalized at shenyang army general hospital to regulate blood glucose because of head pain and high blood glucose. On an unknown date in 2015, the injection pen did not work well but she continued to use it (pc number: (b)(4); batch/lot number: 1112d01). On an unknown date, eyes were not good, her heart was not good, the kidney was also not good (there was the situation of aggravation after using the insulin), the somnus was also not good and blood glucose was also unstable. On an unknown date in 2021, it was difficult to push down the injection button. She pulled out the injection pen after staying at the injection site for 2 min after the injection was complete, there were be drops of insulin out of the injection pen where it dropped out specifically from the injection pen. She also felt that the injection dose of insulin was increased. Originally, a bottle of insulin was used for 16 days, but now it was used up in 15 days. Outcome for the events and information regarding the corrective treatment was unknown. Insulin lispro protamine suspension 50%/insulin lispro 50% therapy was continued. The patient was the operator of the humapen ergo ii device and her training status was unknown. The general model device duration and the suspect device duration of use for humapen ergo ii was around eight years (started in 2013). The suspect humapen ergo ii device status was unknown. The humapen ergo ii (lot number 1112d01) associated with product complaint (b)(4) was not returned to the manufacturer. The reporting consumer did not know about the relatedness between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment. No relatedness was provided between the event and the humapen ergo ii device. Edit 21apr2021: updated medwatch and (b)(6) fields for expedited device reporting. No new information added. Update 04may2021: additional information received on 30apr2021 from global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the (b)(6) device information. Added date of manufacturer for the humapen ergo ii device (lot number 1112d01) associated with product complaint (b)(4) which was not returned to the manufacturer. Corresponding fields and narrative updated accordingly.
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Manufacturer (Section D)
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
640 south rockford drive
tempe AZ 85281
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key11779395
MDR Text Key264514623
Report Number1819470-2021-00060
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1112D01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2021 Patient Sequence Number: 1