Catalog Number 07154003001 |
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 03/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).Medwatch field phone number was provided as (b)(6).
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Event Description
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The customer stated that they received erroneous values for five patient samples tested for crep2 creatinine plus ver.2 (crea) on two cobas 8000 c (701) module - c701 analyzers.The values present in the cobas infinity core middleware system did not match the same values generated by the analyzers for the samples.No erroneous values were reported outside of the laboratory as the crea values in the infinity system were not consistent with values of other renal tests.Refer to the attachment for all patient data.Testing orders were assigned to a c701 analyzer (c701 - line 1), but due to a reagent shortage, no values were generated and reagent shortage messages were transmitted to the infinity system.The infinity then generated values higher than 200 umol/l for these same samples (infinity - line 1 result).The customer saw that the values in the infinity system were too high, so the customer checked the results in the software of the c701 - line 1 system.The customer did not find result values for these samples and the software indicated that there was a reagent shortage.Crea testing for the samples was then manually programmed to be repeated on a second c701 analyzer (c701 - line 2) and the samples resulted with values.Results generated with both c701 analyzers were merged into the customer's laboratory information system (lis).The c701 - line 2 repeat results were the values seen in the lis system.The results from the lis did not match with the infinity results.No adverse events were alleged to have occurred with the patients.The crea reagent lot number and expiration date were asked for, but not provided.
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Manufacturer Narrative
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Investigations of the provided data determined that all affected orders were created from an external host.Messages for creating the order contained a date of birth which was the same date as the order creation date.This means that the patient's age was considered as 0.Patient age is used to calculate the crea result.The results returned by the cobas infinity system are the same as experienced by the customer when the patient's age is 0.As the customer's host system is sending an incorrect date of birth, an unexpected result will occur when calculating the crea result.The customer confirmed that the patient's age was different in their host system than the age that was actually sent to the cobas infinity system.No software issues were found with the cobas infinity system.
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Manufacturer Narrative
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Medwatch field has been updated.
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Search Alerts/Recalls
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