COBAS B 101 HBA1C TEST
Received Dec 4, 2019 · Event occurred Oct 15, 2019
Report 1823260-2019-04244 · MDR key 9410994
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
B 101 HBA1CCatalog number
06378676190
Lot number
929042-01
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
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. RETENTION MATERIAL OF COBAS B101 HBA1C LOT 929042-01 WAS TESTED WITH WHOLE BLOOD MEASUREMENTS AND COMPARED TO TARGET VALUES OBTAINED FROM A TOSOH INSTRUMENT: EIGHT "HIGH" WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 929042-01 ON A RETENTION COBAS B101 INSTRUMENT. NO DISCREPANT HBA1C RESULTS WERE MEASURED WITH RETENTION MATERIAL HBA1C DISC LOT 929042-01. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE HBA1C RESULT FOR ONE PATIENT FROM COBAS B 101 INSTRUMENT SERIAL NUMBER (B)(4). THE RESULT FROM THE B101 WAS 8.2%. THE RESULT FROM AN ANOTHER LABORATORY USING AN UNKNOWN METHOD WAS 7.5%. THE RESULTS WERE REPORTED TO THE PHYSICIAN.