MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-06-20 for DIRECTCHECK, PT ABNORMAL DCJPT-A manufactured by Accriva Diagnostics.
[47791804]
This mdr submitted on 06/20/2016 references accriva diagnostics' complaint number (b)(4). Method: actual device not evaluated. No dhr review was required because the complaint is unrelated to product performance or packaging. Results: no results available since no evaluation performed. Conclusion: human factors issue. Device not returned. Accriva has requested all data required to complete form fda 3500a.
Patient Sequence No: 1, Text Type: N, H10
[47791845]
Accriva's (b)(4) distributor reported that a healthcare professional (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 dropper vial containing diluent. The end-user was wearing gloves and was using the protective sleeve provided with the product. The end user sustained a small cut to the tip of her left index finger from a glass shard that protruded through the dropper vial and the protective sleeve. No significant blood loss or other medical complications were reported. This event occurred outside of the u. S.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00008 |
| MDR Report Key | 5737134 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-06-20 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-06-13 |
| Date Mfgr Received | 2016-06-16 |
| Device Manufacturer Date | 2015-09-11 |
| Date Added to Maude | 2016-06-20 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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, PT ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2016-06-20 |
| Model Number | DCJPT-A |
| Catalog Number | DCJPT-A |
| Lot Number | J5DPA006 |
| Device Expiration Date | 2017-01-31 |
| 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 | 2016-06-20 |