MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-25 for BD KIESTRA? READA COMPACT 447206 manufactured by Bd Kiestra Lab Automation.
[32320235]
The bd kiestra? Reada compact is the incubation and imaging module designed for use with the total laboratory automation (tla) and work cell automation (wca) lines of bd kiestra products. On 11/20/2015 bd quality confirmed during the investigation that a functionality setting in the bd kiestra? Reada compact system which automatically adjusts the timing between images of the dishes to account for any system downtime has been determined to contribute to the reported event. The customer? S settings were changed to prevent this event from reoccurring. Bd has determined through the investigation that no us customer site is impacted by this functionality setting on the bd kiestra? Reada compact system. No device returned.
Patient Sequence No: 1, Text Type: N, H10
[32320236]
The customer is receiving an error pop up window while processing samples using the bd kiestra reada compact. The error itself can be resolved simply by restarting the software. However, if the error goes unresolved the system may begin skipping incubation steps. This caused the final images to be taken prior to the end of their originally programmed incubation periods.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010141591-2015-00003 |
| MDR Report Key | 5249108 |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-10-15 |
| Date Added to Maude | 2015-11-25 |
| 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 | BDX CAROL NIETO |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BD KIESTRA LAB AUTOMATION |
| Manufacturer Street | 6 MARCONILAAN |
| Manufacturer City | DRACHTEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD KIESTRA? READA COMPACT |
| Generic Name | MICROBIOLOGICAL INCUBATOR |
| Product Code | JTQ |
| Date Received | 2015-11-25 |
| Catalog Number | 447206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD KIESTRA LAB AUTOMATION |
| Manufacturer Address | 6 MARCONILAAN DRACHTEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-25 |