MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for PAXGENE? BLOOD CCFDNA TUBE 768165 manufactured by Becton, Dickinson And Company (bd).
[146510795]
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[146510796]
It was reported that paxgene? Blood ccfdna tube gave erroneous results. This occurred on 1000 occasions. The following information was provided by the initial reporter: unsatisfied quality. Due to poor performance compared to competitor's product will be returned. Paxgene ccfdna tube has poor quality on volume of ccfdna and it caused qc fail. ((b)(6)? S guarantee criteria: nipt 10ng/ul: 6 fail out of 17 samples, cancer 40n/ul). In library production step, paxgene tube was shown 37% lower performance in library concentration comparison. Sample condition: same day of collection? Yes. Same phlebotomist? Yes. Tube storage conditions (time and temp before centrifugation): centrifugation. Conditions for both tubes: 2900g / 10mins / 4degree. Tube lot numbers / expiration dates - lot# 8158948 / 31. July. 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00534 |
| MDR Report Key | 8573798 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-06-27 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2018-06-07 |
| Date Added to Maude | 2019-05-02 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAXGENE? BLOOD CCFDNA TUBE |
| Generic Name | DNA TUBE |
| Product Code | PJE |
| Date Received | 2019-05-02 |
| Catalog Number | 768165 |
| Lot Number | 8158948 |
| Device Expiration Date | 2019-07-31 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |