Model Number U1100 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).(b)(4).
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Event Description
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The customer stated that they received erroneous results for one patient urine sample tested for nitrites on urisys 1100 analyzer serial number (b)(4).The erroneous results were reported outside of the laboratory.The sample initially resulted with a positive nitrite value.The sample was repeated and the nitrite value was again positive.The sample was repeated a second time and the nitrite value was negative.The negative value was considered to be ok.No adverse events were alleged to have occurred with the patient.The customer uses combur 7 test strips.The lot number and expiration date of the test strips were asked for, but not provided.The customer suspects that the test strips may have been incorrectly positioned in the analyzer when the test strips were measured.The analyzer appeared to be clean and there were no obvious deposits or debris.
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Manufacturer Narrative
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The test strip lot number was 17822901, with an expiration date of 28-feb-2018.
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Manufacturer Narrative
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Retention test strip material (lot 178229) was tested with a retention urisys 1100 analyzer using native urine, and a leukocyte, protein, and nitrite dilution series.The results of all measurements fulfilled requirements.No false negative or implausible results were observed.One vial of the customer's test strip lot number 17822901 was provided for investigation.The test strips showed discoloration on different test pads.Investigation measurements of the provided test strips was not possible because of the discoloration.The customer's test strips show a typical error pattern caused by humidity.Update: unique identifier (udi)# = (b)(4).
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Search Alerts/Recalls
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