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Model Number MS9675
Device Problem Failure to Deliver (2338)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Shaking/Tremors (2515)
Event Date 03/30/2018
Event Type  Injury  
Manufacturer Narrative
No further follow-up is planned. Evaluation summary: a female patient reported that when using her humapen luxura hd device she did not believe she received any insulin from the injection. She also reported that she has been using the same luxura hd device for over 3 years. The patient experienced increased blood glucose. Investigation of the returned device (batch 1108g04, manufactured august 2011) found the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. There is evidence of improper use. The patient used the device beyond the recommended use period. This may not be relevant to the complaint of increased blood glucose levels.
Event Description
Lilly case id: (b)(6). This report is associated with product compliant: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6)-year-old female patient of unknown origin. Medical history included diabetes diagnosed in 1975. Concomitant medication included insulin detemir for the treatment of type i diabetes. The patient received insulin lispro (rdna origin) injections (humalog) via reusable pen (humapen luxura hd), 12 units for the treatment of type i diabetes. Frequency, route of administration and start therapy date were not provided. On (b)(6) 2018 when she attempted to take 12 units of insulin lispro with her luxura hd pen, she did not believe she received any insulin from the injection; as a result of this missed dose her blood sugar was over 500 (no units provided) for most of the day. She felt light headed and shaky, so she called her health care professional (hcp) and was advised to take 3 units ever three hours until she got her sugar down to 300 (no units provided) and then she could eat and go back to her regular dose schedule. She followed this instruction but her sugar level did not go down and she continued to feel bad; she also tried drinking a lot of water and exercise. Since nothing was working she went to the hospital and was admitted for overnight observation. When she arrived at the hospital her blood pressure was high (no values provided) and her sodium was low (no values provided). By midnight her levels came down and by 9 am of (b)(6) 2018 (next day) they were completely regulated (it was unclear if she was referring to all levels or only to blood sugar levels). It was also reported that she used the luxura hd pen for more than three years and that it was believed that the missed dose was because the cartridge was close to be empty. Information regarding corrective treatments was not provided. She had recovered from the missed dose, of feeling light headed and shaky, the high blood sugar and the low sodium. The outcome of the remaining events was unknown. Insulin lispro treatment status was not provided. The patient was the operator of the humapen luxura hd and her training status was not provided. The general humapen luxura hd duration of use was unknown, but the suspect humapen luxura hd was used for more than three years. The humapen luxura hd was available and its return was expected. The reporting consumer assessed the events of missed dose and feeling light headed and shaky were not related to insulin lispro, that the event of high blood sugar was related and did not know if the low sodium was related. The reporting consumer did not provide an assessment of relatedness for the remaining events and assessed that the events of missed dose, feeling light headed and shaky were related to the humapen luxura hd. This case was cross-referenced to the following case: (b)(4) with the same patient. Edit (b)(6) 2018: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Update (b)(6) 2018 additional information received on (b)(6) 2018 from the global product complaint database. Recoded suspect device from humapen luxura hd pen to sample humapen luxura hd pen. Entered device specific safety summary (dsss). Updated the medwatch/european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer. Added date of manufacturer, date returned to manufacturer for the device, and unique identifier number (udi) for the suspect humapen luxura hd pen of (b)(6) relating to product complaint (b)(4) associated to 1108g04 lot of a sample humapen luxura hd pen. 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 Key7477584
MDR Text Key107076860
Report Number1819470-2018-00057
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
Reporter Occupation
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9675
Device Catalogue NumberMS9675
Device Lot Number1108G04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2011
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: 05/01/2018 Patient Sequence Number: 1