MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,05,consumer,health prof report with the FDA on 2015-07-02 for BD KIESTRA? READA COMPACT 447206 manufactured by Bd Kiestra Lab Automation.
[22452385]
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. Bd has initiated an investigation for this report of premature imaging by the bd kiestra reada compact. Based on the information currently available we are unable to determine the occurrence of the phenomenon or if it would likely cause or contribute to a serious injury or death if it were to recur. Bd will file a supplemental report when the investigation is complete and additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[22452386]
Customer reported that plates inoculated with patient specimen were prematurely imaged by the bd kiestra reada compact when they performed maintenance on the instrument. The plates were automatically removed from the bd kiestra reada compact and sent to the stacker area pending the next step in its process. When the technician "acknowledged" completion of the maintenance, a portion of the plates were moved to the imaging step instead of being returned to incubation. The customer communicated that they recognized the affected plates at the time they were imaged and there has been no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
[28386343]
Bd quality has confirmed that this is the only customer site with this version of bd proceeda? Software. A bd field representative was dispatched to the customer site to correct the customer's programming steps and prevent any further recurrence. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[28386344]
This is a second follow-up for report 3010141591-2015-00001 (fda initial notification 07/02/2015; fda follow-up # 1 on 8/31/2015). This report contains updated information for the manufacturer's narrative only.
Patient Sequence No: 1, Text Type: D, B5
[33268189]
Bd quality has investigated this customer's incident as reported and it has been confirmed. This site is using a customer-requested modified version of (b)(4)? Software. This version permits the customer to have a destination step in the first step of the program and will allow for two (2) different incubation types in one program for an analysis set. When plate incubation is interrupted and then reintroduced into the system, some of the customer's programs could be affected and these plates would move into the next programmed step even if incubation time had not fully passed. This phenomenon is currently under investigation to determine root cause. A corrective action/preventative action (capa) has been opened to address the incident. At this time no trends have been identified. Bd quality will continue to closely monitor for trends. A hard copy of this report was mailed on (b)(4) 2015. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33268190]
This is a follow-up report to report 3010141591-2015-00001 which filed to the fda on (b)(4) 2015. This report contains additional information for the method code, results code, conclusions code and manufacturer's narrative only. A paper copy of this follow-up report was also mailed to the fda on (b)(4) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010141591-2015-00001 |
| MDR Report Key | 4892653 |
| Report Source | 00,04,05,CONSUMER,HEALTH PROF |
| Date Received | 2015-07-02 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-06-03 |
| Date Mfgr Received | 2015-06-03 |
| Date Added to Maude | 2015-07-30 |
| 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 CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 211520000 |
| Manufacturer Country | US |
| Manufacturer Postal | 211520000 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BD KIESTRA LAB AUTOMATION |
| Manufacturer Street | MARCONILAAN 6 |
| Manufacturer City | DRACHTEN FRYSLON 9207JC |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9207 JC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD KIESTRA? READA COMPACT |
| Generic Name | BATH, INCUBATORS/WATER, ALL |
| Product Code | JTQ |
| Date Received | 2015-07-02 |
| Catalog Number | 447206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-07-02 |