COBAS B 101 HBA1C TEST
Received Nov 21, 2019 · Event occurred Nov 1, 2019
Report 1823260-2019-04155 · MDR key 9353382
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
B 101 HBA1CCatalog number
08038694190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AS THE HBA1C DISC LOT NUMBER IS UNKNOWN, NO RETENTION MATERIAL TESTING CAN BE PERFORMED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN: (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF QUESTIONABLE HIGH HBA1C RESULTS FOR 4 PATIENTS TESTED ON A COBAS B101 INSTRUMENT SERIAL NUMBER (B)(4) COMPARED TO AN UNKNOWN LABORATORY METHOD. FROM THE DATA PROVIDED, 1 PATIENT HAD DISCREPANT RESULTS. THE DATE OF THE EVENT IS ONLY AN APPROXIMATION AS THE DATE OF THE EVENT WAS UNKNOWN. THE COBAS B101 HBA1C RESULT WAS 8.1%. THE HBA1C RESULT FROM AN UNKNOWN METHOD AT ANOTHER LABORATORY WAS 7.2%. IT WAS UNKNOWN IF THE RESULTS IN QUESTION WERE REPORTED OUTSIDE OF THE LABORATORY.