Catalog Number 04882458001 |
Device Problems
Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer's meter and barcodes were requested for return.The customer's meter was returned for investigation.The investigation is ongoing.
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Event Description
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The initial reporter alleged that an accu-chek inform ii meter was not correctly scanning patient barcodes.The initial reporter alleged that 3 patient barcodes were incorrectly read and provided one example.The barcode on a patient wrist band should have been (b)(4) but when scanned read (b)(4).The customer stated they have 3 other meters on the floor that all read the barcodes correctly.
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Manufacturer Narrative
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The reporter's meter was returned for investigation.The customer meter barcode functionality was tested using sample barcodes.All barcodes were scanned correctly.No issue was found with the barcode scanning function of the meter.The alleged malfunction was not reproducible with the customer meter.The product performed according to the specifications.Medwatch fields d9 and h3 have been updated.
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Search Alerts/Recalls
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