API® RAPID 20E
Received Jan 17, 2017
Report 3002769706-2017-00005 · MDR key 6258014
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
A CUSTOMER IN (B)(6) REPORTED THEY OBSERVED A LOW SUGAR REACTION, LEADING TO POTENTIAL ORGANISM MISIDENTIFICATION, FOR A URINE SPECIMEN IN ASSOCIATION WITH THE API® RAPID 20E TEST. THE BACTERIA IDENTIFIED BY VITEK® 2 WERE CLOACAE AND SERRATIA. THE CUSTOMER STATED THAT NO DISCREPANT RESULT WAS REPORTED TO A PHYSICIAN AND THAT PATIENT TREATMENT WAS NOT IMPACTED. THE CUSTOMER STATED THERE WAS A ONE-DAY DELAY IN REPORTING RESULTS. THERE MAY BE A POTENTIAL FOR ADVERSE EVENT IF THE EVENT WERE TO REOCCUR; THEREFORE THIS EVENT IS BEING REPORTED AS A MALFUNCTION. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Additional Manufacturer Narrative
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE QUALITY CONTROL LABORATORY TESTED THE ATCC STRAINS REFERENCED IN THE RAPID 20 E PACKAGE INSERT: O ESCHERICHIA COLI ATCC 11775 . O KLEBSIELLA PNEUMONIAE ATCC 35657. O PROTEUS VULGARIS . TESTING WAS COMPLETED ON RETAINED SAMPLES AVAILABLE AT THE MANUFACTURING SITE (LOT 1004905250) AND FROM THE CUSTOMER SITE. THE RETAINED MANUFACTURING SITE LOT CONFORM TO INTERNAL SPECIFICATIONS. THE CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED ON THIS LOT. TESTING ON THE CUSTOMERS LOT ALSO CONFORM TO INTERNAL SPECIFICATIONS. THE CUSTOMER'S COMPLAINT COULD NOT BE REPRODUCED ON THIS LOT.