COBAS B 101 HBA1C TEST
Received Dec 4, 2019 · Event occurred Sep 25, 2019
Report 1823260-2019-04253 · MDR key 9412343
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
B 101 HBA1CCatalog number
08038694190
Lot number
91504101
Product problems
- High Test Results
- High Test Results
Patient
35 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE HEMOGLOBIN A1C RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM COBAS B101 ANALYZER. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. DATA WAS PROVIDED FOR FOUR PATIENT SAMPLES. PATIENT 1 B101 RESULT WAS 6.5% AND THE REPEAT RESULT WAS 5.9%. ON (B)(6) 2019, PATIENT 2 B101 RESULT WAS 7.5% AND THE REPEAT RESULT WAS 6.7%. ON (B)(6) 2019, PATIENT 3 B101 RESULT WAS 7.7% AND THE REPEAT RESULT WAS 7.1%. ON (B)(6) 2019, PATIENT 4 B101 RESULT WAS 8.1% AND THE REPEAT RESULT WAS 7.4%. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED 10 UNUSED DISCS OF COBAS B101 HBA1C TEST DISCS FOR INVESTIGATION. THE BATCH RECORDS OF THE LOT WERE REVIEWED AND SHOWED NO ABNORMALITIES AND ALL FEATURES PASSED. THE LOG FILES FROM THE INSTRUMENT WERE PROVIDED, BUT DID NOT CONTAIN ERRORS. RETENTION MATERIAL AND THE CUSTOMER RETURNED MATERIAL WERE TESTED AND NO DISCREPANT HBA1C RESULTS WERE SEEN. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.