MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-24 for DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL DCJLR-A manufactured by Accriva Diagnostics.
[80968723]
(b)(4). Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[80968724]
Healthcare professional reported that an end user sustained an injury while using a directcheck quality control. This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent. Usage of gloves or the protective sleeve provided with the kit was not specified. The location of the injury, the severity of the injury and the initial treatment of the injury was not specified. The end user went to the emergency room, however the medical care that may have been rendered and if complications occurred was not specified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2017-00001 |
| MDR Report Key | 6738933 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-24 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-07-06 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-07-24 |
| 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 | JON MCDERMED |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2017-07-24 |
| Model Number | DCJLR-A |
| Catalog Number | DCJLR-A |
| Lot Number | J6DLA034 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-24 |