AXSYM MYOGLOBIN 3E43-20

[1034098] The customer stated the reagent pack actuator on the axsym analyzer is not opening the reagent packs. A field service representative confirmed three axsym myoglobin reagent kits were damaged and were the cause of multiple probe crashes on the axsym. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5

[8162799] Investigation in process, no method, results or conclusion can be chosen at this time. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

[8435003] (b)(4). Evaluation result: device component failure due to improper installation of the press plate on a universal press that was used to assemble the axsym reagent pack. The press plate was installed backwards, causing inadequate pressure to consistently secure the flipper bar to the reagent bottle cap. There were seven specific axsym regent packs (axsym hbsag lot 66495m100, axsym cmv igg lot 66577m100, axsym core 2. 0 lot 66253m200, axsym folate lot 68537m100, axsym myoglobin lot 63493m200, axsym troponin-i adv lot 67320m100 and axsym troponin-i adv 67320m101) experiencing an increase in probe crashes in the field due to a separation of the flipper bar from the reagent cap which caused a failure of the reagent caps to open. An investigation determined the root cause of this issue was due to an improper installation of the press plate on the universal press. The press had been installed backwards causing inadequate pressure to consistently secure the flipper bar during kit assembly. Contributing to this issue, was the lack of error proofing for the press plate installation and the variability identified in the way personnel executed the flipper bar check. Corrective actions were identified and implemented to prevent future occurrences. The press plate was stamp labeled with "front" and 'back' to facilitate proper installation. Additionally, the press plate will be redesigned so there will be only one correct way to install the press plate on the universal press. The kit-packing procedural instructions were reviewed and found to provide adequate instructions for rejecting kits; however, the document allowed for variability in the execution of this task. As a result, procedural clarification was implemented. Based on the investigation findings the issue was identified only on the specified seven axsym reagent lots. The customers were instructed if they had any of the identified axsym reagent lots, they were to inspect the reagent pack for broken or improperly sealed caps, to manually open each bottle to ensure it opens properly, to close each flipper bar prior to loading and to discard any reagent packs that did not open properly. Patient results were/are not impacted as any potential failure to actuate prevents generation of results. This is the final report.
Patient Sequence No: 1, Text Type: N, H10