Additional and corrected information: b4, d9, g6, h1, h2, h3, h10 an investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.
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Additional and corrected information: b4, d9, g6, h2, h3, h4, h6, h10.The customer reported an incorrect account number shown when scanned by the statstrip 1.75 meter sn (b)(6).The meter scanned a patient identification number however; received incorrect output that did not match.The customer states they are unaware of any patient harm from the barcode misread and will not be returning the meter as it is currently in use at the facility.To date, the product has not been received for evaluation.Without the returned product a detailed investigation on the failed product could not be performed, and the reported condition could not be confirmed.The cause(s) of the difficulty reported by the customer could not be determined.A device history record (dhr) review for the statstrip meter sn (b)(6) was performed by a quality control engineer.The review included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhr indicated the released product met all specifications.Complaint will be closed as 'no complaint sample returned to nova for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.A capa (corrective and preventative action) is not required as a result of this investigation because the complaint was not confirmed.Nova will continue to monitor for recurrence, no further action is required at this time.
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