MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-08 for MAGNA PURE24 INSTRUMENT 07290519001 manufactured by Stacie-ann Creighton.
[102110357]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The udi for the magna pure 24 instrument is (b)(4), and the instrument is 501k exempt.
Patient Sequence No: 1, Text Type: N, H10
[102110358]
During investigation of a new protocol, an external collaborator identified cross-contamination of samples when running the existing pathogen200 protocol on the magna pure 24 system, when using the rack-based purification run. The customer is utilizing stool samples containing high titer norovirus and rotavirus, and known negative samples are generating cp values. No harm or injury occurred. Results generated have not been used for diagnostic purposes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00002 |
| MDR Report Key | 7325066 |
| Date Received | 2018-03-08 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-08 |
| Date Added to Maude | 2018-03-08 |
| 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 | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAGNA PURE24 INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2018-03-08 |
| Model Number | NA |
| Catalog Number | 07290519001 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STACIE-ANN CREIGHTON |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-08 |