API® RAPID ID 32 STREP
Received Nov 22, 2019
Report 9615754-2019-00132 · MDR key 9366010
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
Additional Manufacturer Narrative
A CUSTOMER IN JAPAN NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING A PATIENT STRAIN WITH THE API® RAPID ID 32 STRIP (REF. 32600, LOT # NOT SPECIFIED). API® RAPID ID 32 STRIP RETURNED A VERY GOOD IDENTIFICATION RESULT TO "STREPTOCOCCUS DYSGALACTIAE SSP DYSGALACTIAE (99.9%), NEXT TAXON STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS (0.1%)." THE FINAL ORGANISM IDENTIFICATION WAS DETERMINED VIA 16S RRNA SEQUENCING AS STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS. IN RESPONSE TO THIS CUSTOMER COMPLAINT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED. THE CUSTOMER HAD NOT TESTED THE QUALITY CONTROL STRAINS. THERE WAS ALSO NO INFORMATION PROVIDED ON THE IDENTIFICATION REPORTED TO PHYSICIAN. WITHOUT THE LOT NUMBER OF THE IMPACTED RAPID ID 32 STRIP AND WITHOUT THE RETURN OF THIS STRAIN, NO FURTHER INVESTIGATION COULD BE PERFORMED WITH THE INFORMATION PROVIDED BY THE CUSTOMER. THE TREND ANALYSIS OF COMPLAINTS DID NOT SHOW ANY DEVIATION FOR RAPID ID 32 STREP, REFERENCE 32600. IT WAS RECOMMENDED TO THE CUSTOMER TO TEST THE THREE QUALITY CONTROL STRAINS STIPULATED IN THE INSTRUCTIONS FOR USE TO VALIDATE THEIR METHODOLOGY. IN ADDITION, THE CUSTOMER WAS ADVISED TO USE THE METHODOLOGY DESCRIBED IN THIS PACKAGE INSERT, IN ORDER TO ELIMINATE ANY RISK OF DEVIATION FROM THE PROTOCOL. IN SUMMARY, NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED.
Description of Event or Problem
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION RESULTS WHEN TESTING A PATIENT STRAIN WITH THE API® RAPID ID 32 STREP (REF. 32600, LOT # NOT SPECIFIED). THE PATIENT STRAIN WAS ISOLATED FROM A SAMPLE OF LIQUID FROM A PUNCTURED DIGESTIVE ORGAN. API® RAPID ID 32 STREP RETURNED A VERY GOOD IDENTIFICATION RESULT TO "STREPTOCOCCUS DYSGALACTIAE SSP DYSGALACTIAE (99.9%), NEXT TAXON STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS (0.1%)." THE FINAL ORGANISM IDENTIFICATION WAS DETERMINED VIA 16S RRNA SEQUENCING AS STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.