| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COULTER ISOTON 4 DILUENT | DILUENT, BLOOD CELL | BECKMAN COULTER | GIF | NA | 8547148 | 18206F | Y | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-19 | 0 |
Patient 1
THE CUSTOMER REPORTED HGB (HEMOGLOBIN) FAILURES AT INSTRUMENT STARTUP ON A COULTER LH 500 HEMATOLOGY ANALYZER, AND REQUESTED A SERVICE VISIT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS.
Patient 1
A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 06/04/2015 AND FOUND INCOMPLETE HGB BACKGROUNDS ON THE INSTRUMENT. THE CAUSE OF THE INCOMPLETE HGB WAS A DIRTY WHITE BLOOD CELL (WBC) BATH AND APERTURE ASSEMBLY. THE BATH AND APERTURE ASSEMBLY WAS REPLACED TO RESOLVE THE INCOMPLETE HGB ISSUE. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(6).
Patient 1
BASED ON ROOT CAUSE, THE SUSPECT PRODUCT WAS IDENTIFIED TO BE THE REAGENT(S) USED WITH THE INSTRUMENT. THE FIRST PRODUCT; SUBSEQUENT PRODUCTS ARE PROVIDED HERE; IT IS UNKNOWN WHICH LOTS WERE IN USE AT THE TIME OF THE EVENT. THEREFORE, EXPIRATION DATE AND DEVICE MANUFACTURING DATE ARE ALSO UNKNOWN FOR THIS EVENT. BRAND NAME: COULTER ISOTON III DILUENT; CATALOG #: 8546733; LOT #: 50793F THROUGH 50818F. BRAND NAME: COULTER ISOTON 4 DILUENT; CATALOG #: 8547148; LOT #: 18206F. BRAND NAME: COULTER LH SERIES DILUENT; CATALOG #: 8547194; LOT #: 510409F THROUGH 510657F; M405237 THROUGH M503553. NEW INFORMATION ABOUT THE ROOT CAUSE WAS COMPLETED ON 8/12/2015. A RECALL WAS COMPLETED AND AN IMPORTANT PRODUCT NOTICE LETTER WAS SENT TO CUSTOMERS ON 09/09/2015. THE ROOT CAUSE HAS BEEN IDENTIFIED AS LOT TO LOT VARIATION IN THE SODIUM SULFATE USED IN THE REAGENT, WHICH RESULTED IN A COMPROMISED WHITE BLOOD CELL (WBC) BATH IN THIS EVENT. IN ADDITION, THE INVESTIGATION FOUND THAT THE ROOT CAUSE IDENTIFIED WOULD NOT CAUSE OR CONTRIBUTE...