MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for DIRECTCHECK QUALITY CONTROL DCJLR-N manufactured by Accriva Diagnostics.
[38771312]
The mdr submitted electronically on 02/10/2016 references (b)(4). Actual device not evaluated. Dhr review was performed. No ncr or any other anomalies related to the complaint were identified. No testing methods performed as the complaint is unrelated to product performance or packaging. (b)(4). Device not returned. Review of this case determined that the end user had not been trained on the proper method to crush the directcheck control vial. Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[38771313]
Healthcare professional reported that she (the end user) sustained an injury during reconstitution of a directcheck quality control. This control is packaged in a glass ampule inside a crushable plastic dropped vial containing diluent. The end-user was wearing gloves but due to a lack of training, she did not utilize the protective sleeve provided with the product. The purpose of the sleeve is to safeguard end users against potential injury during reconstitution of the control. The end user sustained a small cut to the upper portion of her right thumb, which was caused by a glass shard protruding through the dropper vial. The end user rinsed the area immediately, applied pressure to stop the bleeding, and covered the cut with a band aid. No significant blood loss or other medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00002 |
| MDR Report Key | 5429170 |
| Date Received | 2016-02-10 |
| Date of Report | 2016-02-10 |
| Date of Event | 2016-02-09 |
| Date Mfgr Received | 2016-02-09 |
| Device Manufacturer Date | 2015-05-31 |
| Date Added to Maude | 2016-02-10 |
| 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 |
| 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 | 0 |
| Brand Name | DIRECTCHECK QUALITY CONTROL |
| Generic Name | DCJLR-N |
| Product Code | GGN |
| Date Received | 2016-02-10 |
| Model Number | DCJLR-N |
| Catalog Number | DCJLR-N |
| Lot Number | E5DNL017 |
| Device Expiration Date | 2016-02-29 |
| 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 | 2016-02-10 |