FDA Adverse Event
Malfunction
Summary report: N
CALIBRATOR FOR PLATELET COUNTING
MDR report key: 2271292
·
Received October 3, 2011
Report
- Report Number
- 1061932-2011-01609
- Event Type
- Malfunction
- Date Received
- October 3, 2011
- Date of Event
- September 2, 2011
- Report Date
- September 2, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- KRY
- PMA / PMN Number
- K862122
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
THE BECKMAN COULTER INC (BEC) (B)(4) REPRESENTATIVE REPORTED THAT BLOOD ADHERED TO AN S-CAL CALIBRATOR KIT. THE EMPLOYEES WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES, AND FACEMASKS WHEN HANDLING THE REAGENT. NO INJURIES OCCURRED, MEDICAL ATTENTION WAS NOT SOUGHT, AND NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS WAS REPORTED. PATIENT TREATMENT WAS NOT IMPACTED DUE TO THE REAGENT COMPONENT. REVIEW OF PICTURES RECEIVED SHOWED THE PRESENCE OF MULTIPLE SMUDGES ON THE OUT PACKAGE OF THE REAGENT; HOWEVER, THE SOURCE OF THE SMUDGES WAS UNDETERMINED. SERVICE WAS NOT DISPATCHED AND THE ROOT CAUSE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALIBRATOR FOR PLATELET COUNTING | CALIBRATOR FOR PLATELET COUNTING | KRY | BECKMAN COULTER INC. | S-CAL CAL KIT | 1158178F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |