MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-12 for DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL DCJLR-A manufactured by Accriva Diagnostics.
[72672947]
This mdr submitted electronically on 04/12/2017 references accriva diagnostics' complaint number (b)(4). Method code: actual device not evaluated. Dhr review was not performed because the complaint is unrelated to product performance or packaging. Results code: no results available since no evaluation performed. Conclusion codes: 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
[72672948]
Healthcare professional reported that an end user sustained an injury while dispensing a direct check quality control. This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent. The end-user wore gloves and used the protective sleeve provided with the product when reconstituting the control. The purpose of the sleeve is to safeguard the end user against potential injury while handling the control. The end user had difficulty dispensing the control with the dropper vial and removed the protective sleeve. When squeezing vial even harder, the end user sustained a small cut to her right index finger which was caused by a glass shard protruding through the dropper vial. The end user washed the affected area with soap and water and applied a band. No other medical care was required and no complications were documented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2017-00006 |
| MDR Report Key | 6486955 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-04-03 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2017-04-12 |
| 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-LR QUALITY CONTROL, ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2017-04-12 |
| Model Number | DCJLR-A |
| Catalog Number | DCJLR-A |
| Lot Number | M6DLA039 |
| Device Expiration Date | 2018-03-31 |
| 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 | 2017-04-12 |