FDA Adverse Event
Malfunction
Summary report: N
COULTER® S-CAL HEMATOLOGY CALIBRATOR
MDR report key: 2194214
·
Received August 5, 2011
Report
- Report Number
- 1061932-2011-01100
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 7, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- KRY
- PMA / PMN Number
- K862122
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT. (B)(4).
Description of Event or Problem · 1
IT WAS DISCOVERED DURING THE RECEIVING INSPECTION AT BECKMAN COULTER INC. (BEC) AND BEFORE STORING THE PRODUCT INTO THE WAREHOUSE THAT A FOREIGN BODY (RED DOT) SIMILAR TO BLOOD OR RED INK HAD ADHERED TO THE OUTSIDE OF THE COULTER S-CAL REAGENT BOX. IT COULD NOT BE DETERMINED IF THE RED SPOT WAS BLOOD OR INK. EMPLOYEES WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN HANDLING THE REAGENT BOX. THE BOX WAS KEPT IN A PLASTIC BAG AND QUARANTINED AS NON-CONFORMANCE. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER® S-CAL HEMATOLOGY CALIBRATOR | CALIBRATOR FOR PLATELET COUNTING | KRY | BECKMAN COULTER INC. | NA | 1158170F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |