MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-26 for DIRECTCHECK ACT-LR QUALITY CONTROL, ABNORMAL DCJLR-A manufactured by Accriva Diagnostics.
[112456133]
(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. Conclusion: 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
[112456134]
Healthcare professional called to report an end-user injury that occurred during dispensing a directcheck act-lr abnormal liquid quality control. Lyophilized control material is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent. Each directcheck control includes a set of protective sleeves intended to safeguard end-users from potential injury while handling the control. The end-user utilized the protective sleeve when he crushed the ampule to mix the reagent and diluent. He removed the protective sleeve after mixing and squeezed the vial to dispense the reconstituted control. When doing so, a shard of the glass ampuole penetrated the vial and caused a small cut to the right middle finger. The end-user washed the finger with soap and water, then affixed a band aid. Severe bleeding or other medical complications were recorded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00014 |
| MDR Report Key | 7640141 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-06-29 |
| Device Manufacturer Date | 2018-02-05 |
| Date Added to Maude | 2018-06-26 |
| 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 |
| Manufacturer G1 | ACCRIVA DIAGNOSTICS |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| 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 | 2018-06-26 |
| Model Number | DCJLR-A |
| Catalog Number | DCJLR-A |
| Lot Number | B8DLA002 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-06-26 |