Catalog Number 444150 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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While reviewing healthcare records stored on a bd synapsys¿ virtual server laboratory information system (lis), it was determined a certain patient test had become mis-associated with the record of a different patient causing an erroneously associated sample to appear alongside the patient¿s actual sample.The patient had a deep airways specimen cultured in tryptic soy broth and then sub-cultured in agar plates screening for esbl/vre/mrsa/cpe.This patient¿s record had another patient¿s nasal culture also screening for esbl/vre/mrsa/cpe erroneously associated with their record.All relevant plates were indicated in the list as blank (no entry) in the area for entering organisms.There was no indication that the patient was misdiagnosed based on erroneous medical information.
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Manufacturer Narrative
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Investigation summary: during investigation of the issue, a possible data association error in synapsys.This error manifested itself in two noticeable areas.Reading screen images of plate ¿ plates assigned to one specimen had a different accession stamp on the image (this stamp is put on the image by the imaging system in bdk).Culture search ¿ when searching for one specimen within synapsys by accession number, two specimens were returned.During investigation of the customer's database, the following was discovered: it was determined that 3 tests were associated to both specimens.The test hierarchy for these tests had them as children tests to a culture protocol order for specimen ¿a¿ while the specimen link for the tests themselves pointed to specimen ¿b¿.A query was written to find all instances of this mis-association, and it was found that there were 5 distinct instances where this mis-association had occurred.The log entries associated to these tests were reviewed to determine what features were in use at the time of the mis-association and the circumstances around error.The logs identified that the manual inoculation screen in synapsys was where the error occurred.A database change was made to identify the issue over data re-association and disallow it along with a user notification that the potential data re-association was not allowed.This change was made using scr 133223 and was released in the 2.2.2019.01601.The synapsys risk file was reviewed baltrm-synapsys-aph.A new mitigation was added as a result of this complaint (id 50) resulting in the 8f revision of this file.No other trends or new hazards were identified as a result of the complaint investigation.Sa bdds-19-1446-sa was created in response to this complaint investigation.Fa bdds-19-1446-fa has also been created in response to this complaint investigation.Upon investigation, the issue was confirmed as an issue in synapsys and documented in an internal problem tracking tool as scr 133223.This scr was addressed and the resolution was released in synapsys software version 2.2.2019.01601.Complaint confirmed.Root cause determined to be usage of the manual inoculation screen and culture scanning/selection and a combination of browser back/forward buttons.A capa was entered as a result of fa bdds-19-1446-fa indicating that an capa must be automatically generated.
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Event Description
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While reviewing healthcare records stored on a bd synapsys¿ virtual server laboratory information system (lis), it was determined a certain patient test had become mis-associated with the record of a different patient causing an erroneously associated sample to appear alongside the patient¿s actual sample.The patient had a deep airways specimen cultured in tryptic soy broth and then sub-cultured in agar plates screening for esbl/vre/mrsa/cpe.This patient¿s record had another patient¿s nasal culture also screening for esbl/vre/mrsa/cpe erroneously associated with their record.All relevant plates were indicated in the lis as blank (no entry) in the area for entering organisms.There was no indication that the patient was misdiagnosed based on erroneous medical information.
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Search Alerts/Recalls
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