The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed three similar complaints from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number (dyaxac015) are: 1.Inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2018-02855) 2.Inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2020-02325) 3.Unconfirmed as the failure could not be reproduced (reference: mdr number 3006260740-2020-02695).
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of system running slow as unconfirmed.The unit functioned to manufacturer specifications and the reported problem could not be reproduced.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The device was serviced, tested, and returned to the customer.A history review of serial number dyaxac015 showed three similar complaints from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number (dyaxac015) are: 1.Inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2018-02855).2.Inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2020-02325).3.Unconfirmed as the failure could not be reproduced (reference: mdr number 3006260740-2020-02695).H3 other text : evaluation findings are in section h.11.
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