COBAS B 101 HBA1C TEST
Received Jul 17, 2019 · Event occurred Apr 29, 2019
Report 1823260-2019-02634 · MDR key 8798164
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
B 101 HBA1CCatalog number
06378676190
Lot number
835041-01
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. THE CUSTOMER DID NOT PROVIDED THE RESPECTIVE LOT NUMBERS USED. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR COBAS HBA1C TEST ON A COBAS B 101 INSTRUMENT COMPARED TO THE RESULTS FROM AN EXTERNAL LABORATORY. THE HBA1C RESULT FROM THE B 101 WAS 5.7% (39 MMOL/MOL) AND THE HBA1C RESULT FROM THE LABORATORY WITH VENOUS BLOOD WAS 6.5% (47 MMOL/MOL). ON (B)(6) 2019 THE HBA1C RESULT FROM THE B 101 WAS 7.1% (54 MMOL/MOL) AND THE HBA1C RESULT FROM THE LABORATORY WAS 6.5% (47 MMOL/MO). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.
Additional Manufacturer Narrative
THE CUSTOMER PROVIDED THE HBA1C REAGENT LOT NUMBER AND EXPIRATION DATE. MEDWATCH FIELD MODEL #, SERIAL #, EXPIRATION DATE, CATALOG #, LOT #, OTHER #, UDI #. WAS UPDATED.