On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that the casing of her onetouch delica lancing device was cracked and/or broken.The complaint was classified based on information obtained from the customer service representative (csr) documentation.The patient reported that the alleged issue began at an unspecified time on (b)(6) 2017.The patient manages her diabetes with self-adjusted insulin (unspecified type and dose) and she denied making any changes to her usual diabetes management regimen in response to the alleged issue.The patient reported that at an unspecified time on (b)(6) 2017, after the alleged issue had occurred, she ¿passed out¿ and had to be taken to the emergency room (e.R).The patient advised that upon arrival at the e.R, he blood glucose was measured at ¿27 mg/dl¿ on the e.R device (brand not reported) and that she was subsequently treated with a glucagon injection by a healthcare professional (hcp).At the time of troubleshooting, the csr noted that there was no apparent misuse of the lancing device and that it had been in use for approximately 1 month prior to the alleged issue occurring.The csr established that the correct lancets were being used and noted that the lancet gauge was 33g.The subject product was requested back for investigation and a replacement was sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.
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The lay user/patients lancing device has been returned and evaluated by lifescan product analysis with the following findings: the lancing device passed all testing with no faults found.The reported issue could not be confirmed.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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