FDA Adverse Event
Malfunction
Summary report: N
LIQUICHEK TUMOR MARKER CONTROL
MDR report key: 8089923
·
Received November 20, 2018
Report
- Report Number
- 2016706-2018-00006
- Event Type
- Malfunction
- Date Received
- November 20, 2018
- Date of Event
- October 31, 2018
- Report Date
- November 19, 2018
- Manufacturer
- BIO-RAD LABORATORIES
- Product Code
- JJY
- UDI-DI
- 00847661001447
- PMA / PMN Number
- K071675
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2018, BIO-RAD QSD TECHNICAL SUPPORT RECEIVED A CALL FROM BIO-RAD (B)(4) REPORTING A POTENTIAL ADVERSE EVENT. DR. (B)(6) AT HOSPITAL (B)(6) REPORTED THAT MRS. (B)(6), A LABORATORY TECHNICIAN DROPPED LIQUICHEK TUMOR MARKER CONTROL LOT #23951 ON THE FLOOR AND IT SPLASHED INTO HER EYE.
Description of Event or Problem · 1
ON (B)(6) 2018, BIO-RAD QSD TECHNICAL SUPPORT RECEIVED A CALL FROM BIO-RAD (B)(4) REPORTING A POTENTIAL ADVERSE EVENT. DR. (B)(6) AT HOSPITAL (B)(6) REPORTED THAT MRS. (B)(6), A LABORATORY TECHNICIAN DROPPED LIQUICHEK TUMOR MARKER CONTROL LOT #23951 ON THE FLOOR AND IT SPLASHED INTO HER EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 928442 | LIQUICHEK TUMOR MARKER CONTROL | MULTI-ANALYTE CONTROL, ALL KINDS (ASSAYED ) JJY | JJY | BIO-RAD LABORATORIES | 23591 | 00847661001447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |