The defective sample was not returned for further inspection, and no issues were found during the review of internal documentation.Therefore, a root cause cannot be established.Due to the root cause determination, a corrective action has not been taken.An internal complaint (b)(4) was received indicating that a general purpose probe (part m1024231, lot 45601408) failed during use.The end user reported that the temperature readings had significant variances that were resolved by changing the probe.The defective sample was not returned for evaluation.Therefore, a functional inspection of the device could not be performed.The work order for the reported lot was reviewed and no issues were reported during the inspection of the product.Functional results of the sub-assembly work orders assigned to the finished good lot were reviewed, and it was confirmed that, during the functional sampling of the material, all results were found to be within tolerance.The previous two years of internal complaints were reviewed.Similar reports for the same part number could not be identified.Product in process for the sub-assembly was reviewed.At the time of the investigation, 40 units were functionally tested and all results were found to be within tolerance.Inspection of the product is based on an aql of 0.65 percent, level 1.An inventory check at the manufacturing plant also was performed and five lots of the affected sub-assembly were identified.No rejects were generated during the functional inspection of the product.An inventory check was requested at the distribution facility.However, there was no product in storage for the reported finished good number.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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