FDA Adverse Event
Malfunction
Summary report: N
ACCESS® 2 SUBSTRATE
MDR report key: 2365757
·
Received December 12, 2011
Report
- Report Number
- 2122870-2011-06379
- Event Type
- Malfunction
- Date Received
- December 12, 2011
- Date of Event
- November 11, 2011
- Report Date
- November 11, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- LDT
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A CUSTOMER TECHNICAL SERVICE (CTS) ORDERED REPLACEMENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. (B)(4).
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT UPON RECEIPT OF A BOX OF SUBSTRATE SOLUTION IT WAS DISCOVERED THAT ONE OF THE BOTTLE HAD LEAKED INTO THE BOX DUE TO A LOOSE CAP. THE CUSTOMER STATED THAT THE BOX MATERIAL HAD ABSORBED THE SUBSTRATE. THERE WAS NO LEAK OUTSIDE OF THE BOX AND NO ONE CAME INTO CONTACT WITH THE SUBSTRATE MATERIAL. THE CUSTOMER WAS WEARING THE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE). THE CUSTOMER DID NOT REPORT ANY USER INJURY OR MEDICAL INTERVENTION IN ASSOCIATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS® 2 SUBSTRATE | REAGENT, GENERAL PURPOSE | LDT | BECKMAN COULTER INC. | NA | NOT SUPPLIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |