MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-16 for DIRECTCHECK PT QUALITY CONTROL, ABNORMAL DCJPT-A manufactured by Accriva Diagnostics.
[70181353]
(b)(4). Method: actual device not evaluated. Dhr review was not performed because the complaint is unrelated to product performance or packaging. Results: no results available since no evaluation performed. Conclusions: human factors issue. Training deficiency. Device not returned. Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[70181354]
Healthcare professional (the end user) reported that she sustained an injury during administration 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 utilize 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. When squeezing the vial to apply the control to the reagent cuvette, the end user sustained a small cut to her right index finger. This was caused by a glass shard protruding through the dropper vial. The end user cleansed the affected area with an alcohol wipe and a disinfectant sanitizer and applied a band aid. No further medical care was reportedly required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2017-00005 |
| MDR Report Key | 6412106 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2017-03-16 |
| 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 PT QUALITY CONTROL, ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2017-03-16 |
| Model Number | DCJPT-A |
| Catalog Number | DCJPT-A |
| Lot Number | M6DPA005 |
| Device Expiration Date | 2018-01-31 |
| 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 | 62602 SQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-16 |