Additional manufacturer narrative: customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.Lot number 75x178 also provided, but since no specifics were included as to what device issue applied to which lot, referenced here.
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Device distributor reported on behalf of the home care user that the patient had several defective cleo's.When the package was open, it was stated that "most" of them had the adhesive patch stuck on the lid and "some" of them had the adhesive patch completely missing.(specifics on which/how many per lot was not provided).The patient's blood glucose rose to 300 mg/dl and he required multiple daily injections.Trace ketones were noted.No injury was reported.Refer to mfr # 2183502-2016-01433, 2183502-2016-01434, 2183502-2016-01435, 2183502-2016-01436, 2183502-2016-01437, 2183502-2016-01438, 2183502-2016-01439, 2183502-2016-01440, 2183502-2016-01441, 2183502-2016-01442, 2183502-2016-01443, 2183502-2016-01444, 2183502-2016-01445, 2183502-2016-01446, 2183502-2016-01447, 2183502-2016-01448, 2183502-2016-01449, 2183502-2016-01450, 2183502-2016-01451, 2183502-2016-01452, 2183502-2016-01453, 2183502-2016-01454, 2183502-2016-01455, 2183502-2016-01456, 2183502-2016-01457, 2183502-2016-01458, 2183502-2016-01459, 2183502-2016-01460, 2183502-2016-01461.
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