Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a(b)(6) female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog unspecified type) from cartridge, via a reusable pen (humapen, luxura half-dose), at dose of 09 international units, subcutaneously, for treatment of diabetes mellitus, beginning on (b)(6) 2012.On an unknown date, after starting insulin lispro therapy, she had high blood glucose level.On evening of (b)(6) 2022, she was hospitalized due to high blood glucose level (exact values, units and reference range were not provided).Her blood glucose elevated to around 300 (exact values, units and reference range were not provided) and hemoglobin a1c to around 16 (exact values, units and reference ranges were not provided).On (b)(6) 2022, her blood glucose was over 200 (exact value, units and reference range were not provided).On 22-feb-2022, as per her doctor these values would be recovered.Further information regarding hospitalization was not provided.Outcome of the event blood glucose increased was recovering while outcome of event hemoglobin a1c increased was not provided.Insulin lispro therapy was continued.No follow up would be attempted as consumer did not give consent to contact for herself and the doctor of patient for follow up procedures.The operator of the humapen luxura hd was the unknown and his/her training status was not provided.The humapen luxura hd general model duration of use and the suspect humapen luxura hd device duration of use were approximately 121 months.Action taken with the suspect humapen luxura hd was not provided and its return was not expected since there was no issue with it.The initial reporting consumer did not provide relatedness assessment of the events with insulin lispro drug and suspect humapen luxura hd device.Update 01mar2022: additional information received on 01mar2022.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; added the unique device identifier (udi) number.Corresponding fields and narrative updated accordingly.
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