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Model Number MS9673A
Device Problem Break (1069)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hyperglycemia (1905); Hypoglycemia (1912); Missed Dose (2561); Abdominal Distention (2601); No Code Available (3191)
Event Date 10/31/2019
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
Lilly case id: (b)(4). This report is associated with product compliant: this solicited case, reported by a consumer via a patient support program (psp), with additional information from a second consumer via psp, concerned an (b)(6)-year-old female patient of unknown origin. Medical history included a diabetic coma in 2018, before being diagnosed with diabetes. Concomitant medications included insulin glargine. The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) cartridges via a reusable pen (humapen luxura, half-dose pen), subcutaneously, for the treatment of diabetes mellitus, beginning on (b)(6) 2018. She received 4 iu in the morning, 4 iu after lunch and 3 iu at night. In (b)(6) 2019, eight months after starting insulin lispro treatment, she experienced bloating, stomachache and severe abdominal pain. Due to the events of bloating and severe abdominal pain, she was hospitalized in the intensive care unit for two days during (b)(6) 2019. Hospitalization details including specific admission and discharge dates, laboratory examination findings and corrective treatment were not provided. Since (b)(6) 2019, she had bad psychological state. Reportedly, she did not go to her school regularly. Details were not provided. Later, around mid (b)(6) 2019, she had acetone in urine (as reported +4, no reference range provided). This event was considered serious due to its medical significance by the company. Since an unknown date while on insulin lispro treatment, her two humapen luxura, half-dose pen were heavy to push doses, then they began to not function properly (associated product complaints (pcs) 4944606/ lot number 1208g08). She received insulin lispro doses until the pens got stuck, around (b)(6) 2019, she did not miss doses. On (b)(6) 2019, she started to experience high blood glucose level, her blood glucose reached 600 mg/dl; this event was considered serious by the company due to its medical significance. Later her blood glucose decreased to 300 mg/dl then reached 455mg/dl and then on an unspecified date was at 41mg/dl (reference values not provided for all the above). The outcome of the event of blood glucose was 41mg/ml was not provided. She had not recovered from any of the remaining events. Corrective treatment was not reported. Insulin lispro treatment was continued. The user of the humapen luxura, half-dose pens and the training status were not provided. The general humapen luxura, half-dose pen and suspect humapen luxura, half-dose pens duration of use was of twelve months. The humapen luxura, half-dose pens were no longer in use and their return status was unknown. The first reporting consumer related the events of abdominal pain, bloating, acetone in urine and high blood glucose to insulin lispro therapy. The first reporting consumer related the acetone in urine and the blood glucose increased to the humapen luxura, half-dose pens, and did not relate the remaining events to the devices. The second reporting consumer related the event of high blood sugar to the treatment with insulin lispro, did not know if the bad psychological state was related to insulin lispro and did not relate the events of acetone in urine, bloating and stomachache to insulin lispro treatment. The second reporting consumer related the events of acetone in urine and high blood glucose to the humapen luxura hd pen and did not related the events of bad psychological state, bloating and stomachache to the humapen luxura hd pen. No other opinion of causality was provided. Update 11-nov-2019: additional information received on 04-nov-2019 from a second consumer via a psp. Added a new reporting consumer, laboratory data, and the non-serious events of abdominal pain upper, mental disorder and blood glucose decreased. Description as reported of the serious event of blood glucose increased was updated with the following description: then reached 455mg/dl. Narrative and fields were updated accordingly. Edit 18nov2019: updated medwatch fields for expedited device reporting. No new information added. Update 20nov2019: (b)(4) received, processed and added to the narrative. No new information added. Edit 22nov2019: the unique device identifier of (b)(4) for the humapen luxura half-dose devices was added for expedited device reporting.
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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 Key9386360
MDR Text Key185200408
Report Number1819470-2019-00210
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9673A
Device Lot Number1208G08
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2019
Was Device Evaluated by Manufacturer? No
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: 11/27/2019 Patient Sequence Number: 1