Catalog Number 05942861001 |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Quality control tests were performed and passed for both levels.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The meter and test strips were requested for further investigation.The investigation is ongoing.
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Event Description
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There was an allegation of questionable glucose results from an accu-chek inform ii meter.A neonate patient was tested via a heel-stick test with meter uu14477587 at 6:24 am and the result was 38 mg/dl.The operator thought that the result was too low for the patient.Two minutes later at 6:26 am, the patient was retested via heel-stick test with meter uu14477610 and the result was 55 mg/dl.This result was believed correct.
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Manufacturer Narrative
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No customer product was received.Therefore, further investigation was not possible.
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Manufacturer Narrative
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The customer's meter was received for investigation and was tested with retention test strips and quality control materials.Control ranges: level 1: 30-60 mg/dl.Level 2: 261-353 mg/dl.Results: level 1: 43, 44, and 43 mg/dl.Level 2: 297, 297, and 296 mg/dl.All returned results were within acceptable range.The meter log file did not indicate any hardware or software issues that would lead to a measurement discrepancy.The meter was disassembled for further investigation.No damage or contamination was observed.No information was provided that would point to a cause for the result discrepancy.
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Search Alerts/Recalls
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