MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-09 for LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 2 147 manufactured by Bio-rad Laboratories, Inc..
| Report Number | 2016706-2020-00003 |
| MDR Report Key | 9806096 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-11-30 |
| Date Added to Maude | 2020-03-09 |
| 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. MARIA ZEBALLOS |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 9981200136 |
| Manufacturer G1 | BIO-RAD LABORATORIES, INC. |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 2 |
| Generic Name | MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) |
| Product Code | JJY |
| Date Received | 2020-03-09 |
| Model Number | 147 |
| Catalog Number | 147 |
| Lot Number | 23692 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Manufacturer Address | 9500 JERONIMO ROAD IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |