ROCHE DIABETES CARE, INC. ACCU-CHEK AVIVA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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Catalog Number 06453988016 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.
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Event Description
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It was reported the patient received the following results within 15 minutes: 13.0 mmol/l, 21.0 mmol/l, 6.0 mmol/l and 10.0 mmol/l.
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Manufacturer Narrative
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D4 and h4 updated.
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Search Alerts/Recalls
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