![]() ![]() ![]() Were empowering smarter medical and economic decision making to. diagnostics, medical devices, nutritionals and branded generic. ![]() This issue was previously reported under mdr number 3002809144-2019-00856 under the same suspect medical device, but an incorrect manufacturer name, city and state.An investigation was performed for the customer issue, and included a review of the complaint text, a search for similar incidents, a review of trending data, a review of the service history, and a review of product labeling.Similar issues for splashing/pre-trigger exposures were not identified.The current complaint is the sole reportable complaint.No trends were identified.No non-conformances, potential nonconformances, or deviations were identified.A review of the analyzer service history identified no contributing factors on or around the date of the complaint.There have been no subsequent reports from the customer site regarding further splashing/exposure incidents.A cross functional team (cft) determined the incident was due to a use error in that the ambassador did not wear all recommended personal protective equipment while performing service activities that involved contaminated instrument components and chemical hazards.No systemic issue was identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified. This position works out for our facility in Irving, Texas, in the Diagnostics Division. Failure Analysis Engineer at Abbott Diagnostics (retired) Arlington, TX. Violation Tracker, produced by the Corporate Research Project of Good Jobs First, is a wide-ranging database on misconduct by large and small corporations. Three high-sensitivity assays are Food and Drug Administration (FDA) approved for the measurement of troponin (Elecsys 2010 for hs-cTnT, Roche Diagnostics, Penzberg, Germany ARCHITECT i2000SR for hs-cTnI, Abbott Diagnostics, Irving, TX and HsVista for hs-cTnI, Siemens Diagnostics, Newark, DE). ![]()
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |