CHROMID® STREPTO B AGAR
Received Jun 18, 2018
Report 3002769706-2018-00079 · MDR key 7611466
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER IN UKRAINE CONTACTED BIOMÉRIEUX TO REPORT SHRINKAGE OF THE AGAR FOLLOWING INCUBATION IN ASSOCIATION WITH THE CHROMID® STREPTO B KIT. THE CUSTOMER INDICATED A DELAY IN REPORTING OF >24 HOURS DUE TO THE NEED FOR RETEST OF THE SPECIMEN. THE DURATION OF INCUBATION AND THE TYPE OF INCUBATION WERE NOT PROVIDED BY THE CUSTOMER. IT IS ALSO NOTED THE AGAR LOT IN USE WAS WITHIN ONE DAY OF EXPIRATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN TO BIOMÉRIEUX THAT THE DELAY IN REPORTING LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: A DISCREPANCY OR ANOMALY WAS NOT OBSERVED DURING A REVIEW OF THE DEVICE HISTORY RECORDS. THE PRODUCT WAS CONFIRMED TO BE WITHIN MANUFACTURING SPECIFICATIONS. A REVIEW OF THE COMPLAINT HISTORY INDICATED THERE WERE NO OTHER COMPLAINTS SIMILAR IN NATURE TO THE ONE REPORTED BY THE CUSTOMER. AS THE LOT HAD ALREADY EXPIRED WHEN THE INVESTIGATION STARTED, IT WAS NOT POSSIBLE TO INVESTIGATE THE ISSUE ANY FURTHER. AS THE ISSUE IS ISOLATED, NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED. COMPLAINTS WILL CONTINUE TO BE MONITORED ON THIS REFERENCE.