MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-01-19 for LIQUICHEK IMMUNOASSAY PLUS UNK 360 manufactured by Bio-rad Laboratories.
[214817]
Customer stuck self with a syringe containing product from level 2 or 3 of liquichek immunoassay plus. Customer reported incident to technical services. Incident was forwarded to regulatory affairs for follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2001-00001 |
| MDR Report Key | 313904 |
| Report Source | 05,06 |
| Date Received | 2001-01-19 |
| Date of Report | 2001-01-19 |
| Date of Event | 2000-12-05 |
| Date Mfgr Received | 2000-12-05 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2001-01-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | YVETTE LLOYD |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981465 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK IMMUNOASSAY PLUS |
| Generic Name | MULTI-ANALYTE CONTROL (ASSAYED/UNASSAYED) |
| Product Code | JJT |
| Date Received | 2001-01-19 |
| Model Number | UNK |
| Catalog Number | 360 |
| Lot Number | 40570 |
| ID Number | UNK |
| Device Expiration Date | 2002-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 303580 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO ROAD IRVINE CA 92618 US |
| Baseline Brand Name | LIQUICHEK CARDIAC MARKERS |
| Baseline Generic Name | CONTROL (ASSAYED/UNASSAYED) |
| Baseline Model No | NA |
| Baseline Catalog No | 685 |
| Baseline ID | NA |
| Baseline Device Family | CONTROLS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961828 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-01-19 |