FDA Adverse Event
Malfunction
Summary report: N
LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 1
MDR report key: 6953476
·
Received October 16, 2017
Report
- Report Number
- 2016706-2017-00001
- Event Type
- Malfunction
- Date Received
- October 16, 2017
- Date of Event
- September 21, 2017
- Report Date
- October 16, 2017
- Manufacturer
- BIO-RAD LABORATORIES, INC.
- Product Code
- OHQ
- UDI-DI
- 00847661000006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BIO-RAD SHIPPING BOXES WERE LABELED AS REQUIRED BY THE UNITED STATES (B)(4) FOR DRY ICE USING A "MISCELLANEOUS" HAZARD SYMBOL, CLASS 9.
Description of Event or Problem · 1
A CUSTOMER REPORTED RECEIVING SEVERAL BOXES OF BIO-RAD CONTROLS, PACKED WITH DRY ICE. THE SHIPPING BOXES WERE PLACED INTO THE WALK-IN REFRIGERATOR. THE NEXT DAY TWO EMPLOYEES WALKED INTO THE REFRIGERATOR AND REPORTED TO THEIR SUPERVISOR THAT THEY EXPERIENCED A "FEELING OF SUFFOCATION AND/OR THROAT AND CHEST IRRITATION AND DRY MOUTH." BOTH EMPLOYEES WERE SENT TO THE EMERGENCY DEPARTMENT WHERE THEY WERE EXAMINED BY A TOXICOLOGIST MD. THEY RECEIVED AN EKG, PHYSICAL EXAMINATIONS, AND THEIR VITALS WERE MONITORED. THEY WERE SENT HOME. NO HOSPITALIZATION WAS REQUIRED AND NO FURTHER TREATMENT WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 730231 | LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 1 | MULTI-ANALYTE CONTROLS UNASSAYED | OHQ | BIO-RAD LABORATORIES, INC. | 31831 | 00847661000006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |