Model Number 08H67-01 |
Device Problem
High Test Results (2457)
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Patient Problem
No Code Available (3191)
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Event Date 11/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4), patient received salinoferesis.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
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Event Description
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The account stated a newborn patient received salinoferesis due to elevated hematocrit results generated on the cell-dyn ruby.The account stated that although the patient had symptomatic polyglobulia the treatment was unnecessary.The patient was discharged with follow-up checks a few days later.Patient gender was not provided.Patient 3 (b)(6): (b)(6) 2017 hct of 76.4%, (b)(6) 2017 hct of 57.3%, (b)(6) 2017 hct of 54.7%, (b)(6) 2017 hct of 54.7% diagnosis: pre-term newborn 35 weeks normal weight for gestational age, abdominal birth, spontaneous neonatal adaptation, neonatal rds (respiratory distress syndrome) (hyaline membrane disease grade 2, 1 dose of surfactant), metabolic risk, child of a mother with preeclampsia, symptomatic polycythemia, salinoferesis, intolerance to the oral route.
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Manufacturer Narrative
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Field service visited the site on (b)(6) 2017 and ran fl/cal, controls and blood samples.On (b)(6) 2017 field service visited the site again.Controls were within specification, and the blood samples run on the cell-dyn ruby and roche instruments gave hct values of 60% which was close to the cases reported.Additionally, medical affairs reviewed the complaint text and determined that the newborns physiologically have high hgb, hct and mcv values.The reported hct value was above the expected range only for one patient, however the rbc and hgb values were equivalent on the two instruments.The difference in the hct values originated from the difference in mcv.The cell-dyn ruby reported an mcv of 104 fl, while the other analyzer (roche) reported an mcv of 94.8 fl.The difference between these values is larger than expected based on potentially different technology and calibration.However, both values are within physiological range for mcv (for newborns).The discrepancy between the hct values should be confirmed by the reference method (icsh) which is a spun hematocrit; however, reference hct (spuncrit) was not available; therefore, it is not possible to conclude which instrument was more accurate.Hct values fall after birth, so the drop that was seen in these patients was also not unexpected and does not mean that the instrument did not give an accurate hct the first time.Based on the available information, a discrepancy in mcv values was observed between the instruments.Results reported by the cell-dyn ruby were within normal range, and the qc results were also in range; therefore, instrument malfunction could not be concluded.Additionally, the cell-dyn ruby generated dispersional data alerts and flags to alert the operator for the presence of abnormal cell populations which required verification.A review of the product labeling concluded that the issue is sufficiently addressed.A historical data review was performed for the cell-dyn ruby with no issue found during the 12 month search period.Based on the investigation, no product deficiency was identified for the cell-dyn ruby.
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Search Alerts/Recalls
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