MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for BD MAX? SYSTEM 441916 manufactured by Becton, Dickinson & Co..
[28379429]
The bd max system? Is intended for in vitro diagnostic (ivd) use in performing fda cleared or approved nucleic acid testing in clinical laboratories. The bd max system? Is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based pcr. The complaint of? Head moving with door open? Was confirmed onsite by bd service personnel. The field service engineer dispatched to the site found that the door magnet which triggers the door open/closed sensor was out of alignment. The fse adjusted the magnet to resolve the issue, which allows the customer to operate the instrument under normal conditions without further incident. Based on historical data, this is an isolated incident and there are no trends associated with this failure mode. Bd quality will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[28379430]
The customer reported that they were prompted to change the bd max? Pcr cartridge during an interleaved run. When they opened the door of the bd max? Instrument, the head continued to move. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2015-00003 |
| MDR Report Key | 5142034 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-09-15 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2013-07-29 |
| Date Added to Maude | 2015-10-09 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD MAX? SYSTEM |
| Generic Name | REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM |
| Product Code | OOI |
| Date Received | 2015-10-09 |
| Catalog Number | 441916 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-09 |