[60659080]
The customer contacted the siemens customer care center (ccc). Ccc remotely dialed into the instrument and reviewed the instrument data. Ccc discovered that on october 27th, 2016, the prolactin method was calibrated by the customer, and the calibration failed. The customer manually accepted the failed calibration, and quality controls (qc) and patient samples which were subsequently run, resulted out of range. The error log indicated that there were several "aliquot module" and "reagent preparation probe- no cleaner" errors around the time of the failed calibration. A siemens customer service engineer (cse) was dispatched to the customer site for the errors observed. After evaluation of the instrument, the cse tightened the fittings, performed a total service visit and ran qc and a system check, all of which passed. Following the service visit, the customer successfully recalibrated the method, and reran qc, which resulted within range. Patient samples were then repeated, resulting as expected. The cause of the discordant, falsely elevated prolactin results was due to the customer running samples with a failed calibration. This is a user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[60659081]
Discordant, falsely elevated prolactin results were obtained on patient samples on a dimension vista 1500 instrument. The discordant results of four patient samples were reported to a physician(s), who called the customer and questioned two patient sample results. The discordant results of the remaining patients were not reported out, and the samples were automatically rerun on an alternate dimension vista instrument and the repeat results were reported out. The customer performed troubleshooting and repeated the samples of the four patients that were initially reported. The corrected results were reported out to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prolactin results.
Patient Sequence No: 1, Text Type: D, B5