MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-29 for HEMOCHRON JR. DIRECTCHECK, PT ABNORMAL DCJPT-A manufactured by Accriva Diagnostics.
[50816313]
This mdr submitted on 07/29/2016 references accriva diagnostics' complaint number (b)(4). Method codes: actual device not evaluated. No dhr review was required because the complaint is unrelated to product performance or packaging. Results code: no results available since no evaluation performed. Conclusion codes: 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
[50816314]
A healthcare professional reported that an end user sustained a cut to her hand while dispensing a directcheck quality control for a hemochron signature elite and pt/inr microcoagulation system. This control is packaged in a glass ampule contained within a crushable plastic dropper vial containing diluent. The end-user was wearing gloves and when reconstituting the product had used the protective sleeve provided with the product. The injury was caused by a glass shard that protruded through the dropper vial after the protective sleeve was removed. No significant blood loss or other medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00009 |
| MDR Report Key | 5835260 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-14 |
| Date of Event | 2016-07-14 |
| Date Mfgr Received | 2016-07-14 |
| Device Manufacturer Date | 2015-09-11 |
| Date Added to Maude | 2016-07-29 |
| 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 | 3 |
| Brand Name | HEMOCHRON JR. DIRECTCHECK, PT ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2016-07-29 |
| Model Number | DCJPT-A |
| Catalog Number | DCJPT-A |
| Lot Number | J5DPA006 |
| Device Expiration Date | 2017-01-31 |
| Operator | NURSE |
| 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 | 2016-07-29 |