MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2 manufactured by Bio-rad Laboratories.
[127545998]
On (b)(6), a health coordinator from the (b)(6), called bio-rad to inquire about liquichek unassayed chemistry containing any infectious disease material in the product. She stated that a technician splashed a small amount of the level 2 control into her eye while pipetting the control from the primary vial into another vial which was going to be placed on an instrument. They had the technician flushed out the eye with water for several minutes. They also conducted the following medical tests: (b)(6). No other detailed information was provided.
Patient Sequence No: 1, Text Type: N, H10
[127545999]
On (b)(6), a health coordinator from the (b)(6), called bio-rad to inquire about liquichek unassayed chemistry containing any infectious disease material in the product. She stated that a technician splashed a small amount of the level 2 control into her eye while pipetting the control from the primary vial into another vial which was going to be placed on an instrument. They had the technician flushed out the eye with water for several minutes. They also conducted the following medical tests: (b)(6). No other detailed information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2018-00005 |
| MDR Report Key | 8044607 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AZAR KHATIBI |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981210 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 926182017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2 |
| Generic Name | MULTI-ANALYTE CONTROL,UNASSAYED ,PRODUCT CODE OHQ |
| Product Code | OHQ |
| Date Received | 2018-11-06 |
| Lot Number | 31872 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO ROAD IRVINE CA 926182017 US 926182017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-06 |