On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultra2 meter had a calcode issue.The complaint was classified based on customer care advocate (cca) documentation.The patient reported that the issue occurred on (b)(6) 2018 at 08:40am.The patient manages her diabetes with oral medication, diet and exercise and at 12:00pm on (b)(6) 2018 she consumed less food or drink in response to the alleged issue.The patient reported that ¿three hours¿ after the issue occurred she developed symptoms of ¿nervous and shaky¿ however denied receiving any treatment.During troubleshooting the cca noted that the issue was resolved when the patient was walked through changing the calcode.The patient¿s products were 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 adverse event.
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The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the test strips have passed all testing with no faults found.The reported issue could not be confirmed.In addition, lifescan conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.Analysis was not possible for the meter involved with this complaint due unknown storage and handling preventing the allegation being physically investigated.A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.
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