[19842347]
On (b)(6) 2011, patient (patient 1) specimen was tested on stago 1 and indicated a long fibrinogen of <60. The next patient's (patient 2) fibrinogen result was the same. Redraws were requested on both patients. The redraw specimens fibrinogen results on both patients were <60. Reagents were changed, controls were run and results were within acceptable range. The redraw specimens were then retested and had the same <60 results. Patient results were verified. Later, testing was switched to stago 2; repeat testing of all patient specimens indicated fibrinogen values were within normal range. A third specimen was received on one of the patients, also run on stago 1 and had a normal result. This specimen was placed on stago 2 and returned a normal result. The previous 4 specimens were then retested on stago 1 and two of four patient specimens were within normal range, two specimens were <60. The problem appeared to be random. No operational error codes were indicated on stago 1 other than a maximum time error. (please see attachment 1: technologist information). Please note: manufacturer pm on the instrument (stage 1) had been performed 4 days before; no problems were reported. When the manufacturer's technician came in to examine the instrument, as part of this investigation, he found that needles 1 and 3 were hesitating, which threw off the timing of the test; he replaced the tubing in, and the cables on, needles 1 and 3. (please see attachment 2: stago service documentation).
Patient Sequence No: 1, Text Type: D, B5