ELECSYS VITAMIN B12 II
Received Jul 24, 2023 · Event occurred Jul 5, 2023
Report 1823260-2023-02416 · MDR key 17376144
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Roche DiagnosticsModel number
B12 G2Catalog number
07212771190
Lot number
70733100
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS (B)(6). INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. THE CUSTOMER REPLACED THE REAGENT AND PERFORMED A NEW CALIBRATION. THE CUSTOMER HAD NO FURTHER ISSUES. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
ROCHE DIAGNOSTICS RECEIVED AN ALLEGATION OF THREE QUESTIONABLE ELECSYS VITAMINE B12 G2 RESULTS FROM THE COBAS E 411 IMMUNOASSAY ANALYZER. PATIENT SAMPLE 01 INITIAL RESULT WAS 187 PG/ML AND THE RERUN IN ANOTHER ANALYZER WAS 269 PG/ML. PATIENT SAMPLE 02 INITIAL RESULT WAS 124 PG/ML AND THE RERUN IN ANOTHER ANALYZER WAS 222 PG/ML. PATIENT SAMPLE 03 INITIAL RESULT WAS 149 PG/ML AND THE RERUN IN ANOTHER ANALYZER WAS 287 PG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE REAGENT PACK USED FOR THE QUESTIONABLE RESULTS WAS FIRST REGISTERED ON THE ANALYZER ON 26-JUN-2023 AND NO NEW CALIBRATION WAS PERFORMED. THE CUSTOMER HAD PERFORMED A LOT CALIBRATION WITH A DIFFERENT REAGENT PACK ON (B)(6) 2023. THE CUSTOMER DID NOT FOLLOW THE RECCOMENDATIONS FOR CALIBRATION FREQUENCY. PRODUCT LABELING STATES: "RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS: AFTER 1 MONTH (28 DAYS) WHEN USING THE SAME REAGENT LOT. AFTER 7 DAYS (WHEN USING THE SAME REAGENT KIT ON THE ANALYZER). AS REQUIRED: E.G. QUALITY CONTROL FINDINGS OUTSIDE THE DEFINED LIMITS." THE CUSTOMER DID NOT PERFORM QC ON THE DAY OF THE EVENT. PRODUCT LABELING STATES: "CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION." BASED ON THE INFORMATION PROVIDED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT KIT OR LOT ISSUE IS NOT SUSPECTED, AS THE QC WITH THE RELEVANT KIT WAS ACCEPTABLE ON THE DATE THE KIT WAS REGISTERED, AND ANOTHER KIT FROM THE SAME REAGENT LOT PERFORMED WELL. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A USE ERROR AT THE CUSTOMER SITE.