MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-11 for DIRECTCHECK ACT-LR QUALITY CONTROL, NORMAL DCJLR-N manufactured by Accriva Diagnostics.
[108260732]
This mdr submitted electronically on 05/11/2018 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. Fields for which data were not obtainable or are not applicable are intentionally left blank.
Patient Sequence No: 1, Text Type: N, H10
[108260733]
Healthcare professional reported that an end user sustained an injury while handling a directcheck quality control. This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent. The end user crushed the vial to reconstitute the control and sustained a small cut to her right index finger which was caused by a shard of glass. The end-user wore gloves but failed to utilize the protective sleeve provided with the product. The purpose of the sleeve is to safeguard the end user against potential injury while handling the control. The end user filed a report with her supervisor and was seen by occupational health. No lab tests were drawn and general site care was performed. The next day, the end user followed up with occupational health. The puncture site showed no problems and was healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00011 |
| MDR Report Key | 7509440 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-06 |
| Date of Event | 2018-05-05 |
| Date Mfgr Received | 2018-05-06 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-05-11 |
| 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 |
| 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, NORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2018-05-11 |
| Model Number | DCJLR-N |
| Catalog Number | DCJLR-N |
| Lot Number | H7DNL023 |
| Device Expiration Date | 2018-04-01 |
| 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 | 2018-05-11 |