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Model Number UNKNOWN
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
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 complaint: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old asian female patient. Medical history included penicillin and pioneer allergy, the brain was not good to use, could not remember and was hospitalized for unknown reason. Concomitant medication included insulin detemir for diabetes mellitus, unspecified medication for the treatment of diabetes mellitus and unknown long-acting insulin for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 75/25) unknown formulation via reusable device (humapen, unknown device), four units thrice a day, subcutaneously, for the treatment of diabetes mellitus, beginning on (b)(6) 2019 while in hospital. On (b)(6) 2019 night, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, the blood glucose (bg) was high pre-prandial blood glucose value and postprandial blood glucose value was both more than 20 (no units and reference ranges were provided). After she was discharged from the hospital, the bg was as high as 20 points a few. According to the doctor advice, the dosage of humalog was adjusted to six units in the morning, seven units in the noon and in the night. After adjusting the dose, the bg was still sometimes high and sometimes low (no values were provided). She had situations that blood sugar was not well controlled, blood sugar was low, she was feeling unwell and having an unspecified injection. On (b)(6) 2019 night, the blood glucose was higher than 23 points. On an unknown date, her brain was not clear, other information was not obtained. As of (b)(6) 2019, the first day after hospitalization three months ago, the bg situation was always not good. Only two or three times, the bg situation was normal. When the bg was high, it was more than 20. When the blood glucose was low, it was only 2-3, 3-4. The serious event of bg decreased was consider serious due to medical significance. On an unknown date, when her blood glucose was low, it was so low, the eyes could not see clearly. On an unknown date, humapen (unknown device) was broken due which she injected inaccurate dose of insulin lispro protamine suspension 75%/insulin lispro 25% and she had high blood glucose and she appeared uncomfortable. The information regarding other corrective treatment and outcome for the events was not provided. Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was ongoing. The patient was the operator of the humapen (unknown device) and his training status was not provided. The humapen (unknown device) model duration of use was not provided. The suspect humapen (unknown device) duration of use was approximately one year as it was started in 2019. The action taken with the suspect humapen (unknown device) and its return status was not provided. The reporting consumer did not provide the relatedness opinion between the events and insulin lispro protamine suspension 75%/insulin lispro 25% treatment. The reporting consumer related the events of incorrect dose administered, high blood sugar (second episode) and uncomfortable to humapen (unknown device) issue and did not provide a relatedness assessment for the remaining events to humapen (unknown device). Update on 24-may-2019: this case was determined to be non-valid as there was no identifiable product. Update on 19-jun-2019: this case was initially determined to be non-valid (no identifiable suspect product). Additional information was received from initial reporting consumer via psp on 11-jun-2019, which contained a valid product. Added height, weight and ethnicity for patient, two medical histories of penicillin allergy and hospitalization, lab data for blood glucose, insulin detemir as concomitant medication, dosage regimens for insulin lispro and two new non-serious events of blood glucose decreased and cerebra disorder. Updated the product coding from insulin lispro unknown to insulin lispro regular formulation and action taken from no change to dose increased. Updated the narrative with new information. Update on 20-jun-2019: upon review of the information received on 11-jun-2019, updated the product coding from insulin lispro regular formulation to insulin lispro unknown formulation. Updated narrative with new information. Update on 16-jul-2019: the case was upgraded to serious after additional information was received on 04-jul-2019 from initial reporter. Updated the suspect medication for more appropriate coding. Added two lab data for blood glucose (bg). Updated the description as reported for the event bg increased. Added a serious event of bg decreased. Updated the narrative with new information. Update on 03-jan-2020: additional information received from initial consumer reporter on 30-dec-2019, via psp. Added two medical histories of brain not good and forgetfulness, an unspecified medication in narrative for diabetes mellitus and a non-serious event of malaise. Updated narrative with new information. Update on 03-mar-2020: additional information received from initial consumer reporter via psp on 26-feb-2019. Added suspect humapen (unknown device), non-serious events (visual impairment, incorrect dose administered, second episode of high blood sugar and uncomfortable). Updated the causality statement and narrative with new information. Update on 06-mar-2020: product complaint number was received on 04-mar-2020 from rcp. No other changes were made to the case. Edit on 16mar2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added.
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Manufacturer (Section D)
lilly corporate center
indianapolis, in
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
MDR Report Key9871593
MDR Text Key189483541
Report Number1819470-2020-00023
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
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 Treatment Data
Date Received: 03/24/2020 Patient Sequence Number: 1