| Model Number 256041 |
| Device Problem
False Positive Result (1227)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/30/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Multiple lot numbers: there were multiple lot numbers reported to be involved in facility during this time.The information for each lot number is as follows: medical device lot #: 9091948.Medical device expiration date: 2021-08-26 device manufacture date: 2019-04-01 medical device lot #: 9210604 medical device expiration date: 2021-12-16 device manufacture date: 2019-07-29 medical device lot #: 9239994 medical device expiration date: 2021-12-16 device manufacture date: 2019-08-27 medical device lot #: 9259285 medical device expiration date: 2022-02-14 device manufacture date: 2019-09-16 medical device lot #: 9324727 medical device expiration date: 2022-04-25 device manufacture date: 2019-11-20 medical device lot #: 9324730 medical device expiration date: 2022-04-25 device manufacture date: 2019-11-20 medical device lot #: 0041313 medical device expiration date: 2022-10-11 device manufacture date: 2020-02-10 a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported while testing with bd veritor¿ system for rapid detection of flu a + b laboratory kit a false positive result was obtained.Confirmatory pcr testing was performed and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: (15 of 28 patients).The results of an audit done at geraldton hospital shows and increase in false positives when confirmed by pcr or gene xpert.Pcr part of a multiplex assay which uses in house reagents.
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Manufacturer Narrative
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H6: investigation summary : bd point of care quality initiated investigation on the customer report regarding alleged false positive when using the kit flu a+b 30 test hospital veritor ref# (b)(4).Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.There was no lot number documented in the submission of this complaint; therefore no internal investigations can be performed and the issue cannot be confirmed.No returns were received to investigate.The investigation did not find a root cause for the false positive results reported.In a follow-up, customer indicated that the issue was resolved by vortexing the specimen and running the specimen without delay.Bd cannot confirm the complaint based on the investigation that was performed.Bd point of care will continue to closely monitor for trends associated with false positive when using the kit flu a+b 30 test hospital veritor ref#(b)(4).There was no corrective action taken at this time.
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Event Description
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It was reported while testing with bd veritor¿ system for rapid detection of flu a + b laboratory kit a false positive result was obtained.Confirmatory pcr testing was performed and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: (15 of 28 patients).The results of an audit done at geraldton hospital shows and increase in false positives when confirmed by pcr or gene xpert.Pcr part of a multiplex assay which uses in house reagents.
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Search Alerts/Recalls
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