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Model Number MS9673A
Device Problems Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)
Patient Problem Hypoglycemia (1912)
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative
Narrative field: new, updated, and corrected information is referenced within the update statements. No further follow-up is planned. Evaluation summary: the mother of a male patient reported that her son's humapen luxura hd device "sometimes dispensed insulin while injecting and sometimes not as when his mother adjusted the pen on 0. 5 iu, it used to release them in the form of three drops, but now it released only as a one drop and sometimes did not release insulin at all. " the patient experienced a serious event of decreased blood glucose and a non-serious event of increased blood glucose. The device was not returned to the manufacturer for investigation (batch number: 1208g08, manufactured: august 2012). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review and trend review for the device batch did not identify any atypical findings with regard to dose accuracy or device not working issues. All humapen luxura hd 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
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old male patient of unknown origin. Medical history included diabetic coma in 2018 and suffered from high levels of acetone in blood, and then diagnosed with diabetes. He took insulin glargine for diabetes, and had hypoglycemia. Concomitant medication, included insulin degludec for the treatment of diabetes. The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a re-usable device humapen luxura hd, 1 iu, subcutaneously for the treatment of diabetes, beginning in 2018. Dosing frequency was not provided. On an unknown date, humapen luxura hd fell in water and got rusted. Approximately since (b)(6) 2019, or before that (as reported), he started taking insulin lispro via a reusable device humapen luxura hd (second). In (b)(6) 2020, he was admitted to the hospital due to low blood glucose level and intestinal catarrh and admitted almost for a week. On an unknown date, his dose was decreased to (b)(4) iu due to an unknown reason. On an unknown date, second humapen luxura hd got impaired as it sometimes dispensed insulin while injecting and sometimes not as when his mother adjusted the pen on (b)(4) iu, it used to release them in the form of three drops but now it released only as a one drop and sometimes did not release insulin at all (product complaint number (b)(4); lot number: 1208g08). Reportedly, he was taking inaccurate doses due to second humapen luxura hd issue, which led to high blood glucose level. Outcome of the events low blood glucose level and intestinal catarrh was resolved. Further information regarding corrective treatment and outcome of the remaining events was not provided. Status of insulin lispro treatment was continued. The operator of humapen luxura hd devices was mother of patient and her training status was not provided. The general humapen luxura hd duration was approximately 1 year and 10 months and first suspect device was started in 2019, and second humapen luxura hd suspect device was started approximately in (b)(6) 2020, or before that. The status of first humapen luxura hd device and information regarding its return was not provided and second humapen luxura hd was ongoing. The humapen luxura hd (lot number 1208g08) associated with (b)(4) was not returned to the manufacturer. The initial reporting consumer did not provide an opinion of relatedness between the events and insulin lispro treatment. The reporting consumer did not provide relatedness assessment of low blood glucose, and did not associate remaining events with first humapen luxura hd. The reporting consumer related the events of missed dose and inaccurate dose with the product complaint associated with second humapen luxura hd, and did not provide relatedness of remaining events with second humapen luxura hd. Update 25-oct-2020: two documents received on 20-oct-2020 were processed at same time. Edit 28-oct-2020: upon review of the information received on 20-oct-2020, updated insulin glargine (lantus) from co-suspect to historical drug, coding of humapen luxura (from unknown body type to luxua hd), first humapen luxura hd from concomitant device to suspect device and narrative accordingly. Update 05nov2020: additional information was received on 03nov2020 and 04nov2020 from the global complaint database processed together. Entered device specific safety summary (dsss). Updated the medwatch fields with device information, the european and canadian (eu/ca) device information. Added unique identifier number and date of manufacturer for the suspect humapen luxura hd (lot number: 1208g08) associated with (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)
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key10813976
MDR Text Key217646249
Report Number1819470-2020-00152
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 company representative,consum
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot Number1208G08
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2012
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: 11/09/2020 Patient Sequence Number: 1