Catalog Number 11896954176 |
Device Problem
Missing Information (4053)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The reporter's product was requested for investigation.The retention material of lot 38308901 was visually checked.The retention material showed no missing labels on the cardboard box and no missing label on the test strip vial.
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Event Description
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The initial reporter stated that the label containing the result interpretation color scale, lot number, and expiration date was missing from one vial of combur 5 test strips.No adverse events were alleged to have occurred as a result of the incident.
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Manufacturer Narrative
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The customer returned one test strip vial for investigation.It was determined the label on the test strip vial was missing.The packaging line data was reviewed and the line log book showed no abnormalities.The packaging line is equipped with checking devices.The investigation determined a technical failure from the checking system was the root cause.As only a single vial was affected, systematic failure of the checking system is unlikely.There is no risk to patients as the test is visual and the result cannot be read because the color scale is missing from the vial.
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Search Alerts/Recalls
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