MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-09 for DIRECTCHECK ACT+ NORMAL DCJACT-N manufactured by Accriva Diagnostics.
[54401321]
(b)(4). Actual device not evaluated. Process evaluation was not performed as the complaint is not related to product performance or packaging. No testing methods performed. Results: no results available since no evaluation performed. Conclusions: human factors issue. Training deficiency. Device not returned. Since this complaint is not related to product performance and the device will not be evaluated, this submission is considered a final report. Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[54401322]
Healthcare professional reported that an end user sustained an injury during reconstitution of a directcheck quality control. This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent. The end user was wearing gloves but did not use the protective sleeve provided with the product. The purpose of the sleeve is to safeguard the end user against potential injury during reconstitution of the control. After crushing the vial, the end user squeezed the vial to dispense the quality control material and a glass shard protruded through the dropper vial and caused a small laceration on the user's right thumb. The end user immediately washed the area with soap and water and covered the cut with a band aid. No further medical attention was sought. No significant blood loss or medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00011 |
| MDR Report Key | 5941543 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-01 |
| Device Manufacturer Date | 2016-02-16 |
| Date Added to Maude | 2016-09-09 |
| 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 | 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+ NORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2016-09-09 |
| Model Number | DCJACT-N |
| Catalog Number | DCJACT-N |
| Lot Number | B6DNA006 |
| Device Expiration Date | 2017-08-31 |
| 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 CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-09 |