Model Number HBA1C TQ G3 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Event Description
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There was a complaint of a questionable hba1c iii tina-quant hemoglobin a1c iii result for 1 patient tested with a cobas 4000 c311 stand alone system.The questionable result was reported outside the laboratory, and a correction was sent.The customer alleges the issues started with a new reagent pack.The patient¿s initial result was 6.1%; the repeat was 7.4%.The customer believes the repeated result to be correct.The hba1c iii tina-quant hemoglobin a1c iii used was lot 543874 and the expiration date was requested, but not provided.The cobas 4000 c311's serial number is (b)(4).
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Manufacturer Narrative
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The customer changed calibration material, water, and the reagent pack as troubleshooting.They had the same issue.There was a calibration flag that indicated deteriorated calibrator or reagent pack.There are no further issues reported.The investigation is ongoing.
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Manufacturer Narrative
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The qc was recovering low and did not meet acceptance criteria on (b)(6) 2021.The reagent pack was last calibrated on (b)(6) 2021.The investigation found calibration alarms on the calibration documentation.The customer had preventative maintenance performed on the analyzer on (b)(6) 2021.A replacement calibrator pack sent for troubleshooting purposes resolved the issue.There have been no further issues reported.
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Search Alerts/Recalls
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