ANALYTICAL P MODULE 03738965692

[79032065] (b)(4). Unique identifier (udi): na.
Patient Sequence No: 1, Text Type: N, H10

[79032066] The customer stated that they received erroneous results for two patient samples tested for tg triglycerides gpo-pap (trig) on an analytical p module (pmod). Of the two samples, one had an erroneous initial result that was reported outside of the laboratory to the physician. The repeat result was believed to be correct. The sample was processed on an modular preanalytics system (mpa) prior to testing on the p module. As the sample had already come processed from another facility where the sample was collected, the sample was not centrifuged on the mpa system. There was some fibrin in the sample tube. The sample initially resulted as 475 mg/dl. The sample was repeated three times on (b)(6) 2017, resulting as 83 mg/dl, 81 mg/dl, and 83 mg/dl. The patient was not adversely affected. The trig reagent lot number was 21191101, with an expiration date of 01/31/2018. The field service engineer determined that the rinse mechanism was misadjusted. He adjusted the rinse mechanism so that it was within specifications and replaced a heat cut filter. The operator ran calibrations, quality controls, and patient samples; all were ok. The customer later called back and stated that they received erroneous results for four additional patient samples tested for trig on (b)(6) 2017 after service actions had been performed. No erroneous results were reported outside of the laboratory for these samples. The customer was advised to change the reagent bottle with one from a new shipment, then run precision studies with the new bottle. The customer did this and stated that there was one outlier result with the precision. Based on this precision study, it was agreed that there was not a reagent shipment issue. The field service engineer returned to the site and found a faulty gear pump head, causing a fluidics failure. He replace the gear pump head, vacuum diaphragm, valves, the heat cut filter, cells, and lamp. He ran precision studies.
Patient Sequence No: 1, Text Type: D, B5

[120549110] The customer encountered erroneous results for two additional patient samples tested for trig. The erroneous results for these samples were not reported outside of the laboratory. The field service engineer and field application specialist determined that there was a possible carryover issue. A third party test was installed on the analyzer, but the appropriate washes were not programmed on the instrument. The reaction cells on the instrument were changed and the location of the third party reagent was moved. Proper washes were programmed on the analyzer and precision testing was performed for trig; all results were within specifications. No further sample issues were encountered.
Patient Sequence No: 1, Text Type: N, H10