On (b)(6) 2017, a reporter for the lay user/patient contacted lifescan (lfs) alleging that the patient¿s onetouch ultra2 meter kit was missing test strips and control solution.The complaint was classified based on customer care advocate (cca) documentation as the patient was not available when medical surveillance attempted to follow-up to obtain additional information relating to the complaint.The reporter could not specify when the issue was identified, but stated that the patient got the device on (b)(6) 2016.The patient manages her diabetes with fixed insulin doses and exercise.The reporter detailed that an unspecified time after the alleged issue occurred the patient developed symptoms of ¿frequent urination, diarrhea and kidney failure¿ and that on (b)(6) 2017 the patient was hospitalized where she had her blood glucose tested, but the reporter could not specify the results, and the patient was treated with iv fluids.During the call, it was determined that when the reporter was educated on the correct box contents there was no product missing.The product was replaced and requested back.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event after the alleged product issue began.
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