MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-23 for DIRECTCHECK ACT-LR ABNORMAL QUALITY CONTROL DCJLR-A manufactured by Accriva Diagnostics.
[60867731]
(b)(4). Method: actual device not evaluated. Dhr review was not performed as the complaint is unrelated to product performance or packaging. No testing methods performed. 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
[60867732]
Healthcare professional reported that an end user sustained an injury during reconstitution of a directcheck quality control. This control is packaged in a glass ampule inside a crushable plastic dropped vial containing diluent. The end-user was wearing gloves but it is unknown whether or not she utilized the protective sleeve provided with the product. The purpose of the sleeve is to safeguard end users against potential injury during reconstitution of the control. The end user sustained a small cut to an unspecified hand, which was caused by a glass shard protruding through the dropper vial. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00015 |
| MDR Report Key | 6126521 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-11-16 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2016-03-17 |
| Date Added to Maude | 2016-11-23 |
| 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 | DIRECTCHECK ACT-LR ABNORMAL QUALITY CONTROL |
| Generic Name | DCJLR-A |
| Product Code | GGN |
| Date Received | 2016-11-23 |
| Model Number | DCJLR-A |
| Catalog Number | DCJLR-A |
| Lot Number | C6DLA014 |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-11-23 |