Model Number B 101 HBA1C |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter received questionable result hemoglobin a1c results for three patient samples from cobas b 101 instrument serial number (b)(4).The samples were repeated in another laboratory with an unknown method.Patient 1: b101 result was 7.9% and the repeat result was 7.2%.Patient 2: b101 result was 7.3% and the repeat result was 6.5%.Patient 3: b101 result was 8.3% and the repeat result was 7.4%.The questionable results were reported outside of the laboratory.
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Manufacturer Narrative
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The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.Retention material of cobas b101 hba1c lot 931043-01 was tested with whole blood measurements and held against target values obtained from a tosoh g8 instrument: a) eight low whole blood samples were measured with retention material of cobas b101 hba1c lot 931043-01 on a retention cobas b101 instrument.B) eight middle whole blood samples were measured with retention material of cobas b101 hba1c lot 931043-01 on a retention cobas b101 instrument.The product meets specification.Retention material testing and manufacturer final product inspection were successful.The retention material measurements on the retention cobas b101 instrument showed no hba1c deviation compared to tosoh g8.
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Search Alerts/Recalls
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