Model Number INNOVANCE® D-DIMER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) and a technical application specialist (tas) were dispatched to the customer's site to determine the cause of the potential false negative d-dimer result on the bcs xp system.During the investigation, the cse observed that the calibration curve, used to run patient samples, on the bcs xp system was unacceptable.The cse changed the reagent lot, calibrated the system, replaced the sample probes, and flushed the bcs xp system of the barbicide disinfectant cleaner.The precision test, validation and lamp were within specifications.The internal qc recovered within expected ranges.Upon further investigation, siemens determined that the customer is using recycled cuvette rotors.Based on the bcs® xp system's instruction manual, cuvettes are only intended for single use.If used more than once, this could result in inaccurate measurement results.The use of recycled cuvette rotors is a user error and potentially contributed to the discordant result.Siemens has instructed the customer to discontinue the use of recycled cuvette rotors.The system is performing according to specifications.No further evaluation of this system is required.Mdr 9610806-2017-00099, mdr 9610806-2017-00100, mdr 9610806-2017-00101, and mdr 9610806-2017-00102 were filed for the same event.
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Event Description
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A potential false negative d-dimer result was obtained on a patient sample using an unacceptable calibration curve on the bcs xp system.The d-dimer result was reported to the physician, who did not question the result.The affected patient sample was not rerun and a corrected report was not provided to the physician.The correct result for the affected patient is unknown.There are no known reports of patient intervention or adverse health consequences due to the potential false negative d-dimer result obtained on a patient sample on the bcs xp system.
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Manufacturer Narrative
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Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00098 on september 13, 2017.Additional information (september 18, 2017): the customer indicated that they will discontinue the use of recycled cuvette rotors.The customer resumed the use of barbicide disinfectant and the customer has not experienced any issues since they used new cuvette rotors for sample and control determination.Additional information (september 21, 2017): since september 11, 2017, all d-dimer quality controls recovered within expected ranges.The internal quality controls for the other assays also recovered within expected ranges.Additional information (september 22, 2017): a siemens headquarters support center (hsc) specialist reviewed the event and field service reports and determined that the cause of the potential false negative d-dimer result on the bcs xp system was due to the customer's use of recycled cuvette rotors.Mdr 9610806-2017-00099_s1, mdr 9610806-2017-00100_s1, mdr 9610806-2017-00101_s1, and mdr 9610806-2017-00102_s1 were filed for the same event.
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Search Alerts/Recalls
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