MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-01 for DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL DCJLR-A manufactured by Accriva Diagnostics.
[86094142]
This mdr submitted electronically references accriva diagnostics' complaint number (b)(4). Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[86094143]
Healthcare professional reported that an end user sustained an injury while dispensing a directcheck quality control. This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent. The report did not specify whether the end user wore gloves or used the protective sleeve provided with the product when reconstituting the control. Circumstances of the injury were not specified other than the injury occurred on the subject's right thumb. Immediate and follow-up care was not specified. No complications were documented. Three calls were made to the end user to seek the lot number and expiration data of the device implicated in this complaint. The end user was non-responsive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2017-00004 |
| MDR Report Key | 6840403 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-01 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-09-01 |
| 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 | 2017-09-01 |
| Model Number | DCJLR-A |
| Catalog Number | DCJLR-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-01 |