MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-08-25 for WALKAWAY 96 PLUS N/A B1018-284 manufactured by Beckman Coulter.
[24797995]
The data for the high probability identification of escherichia coli was not available as the customer did not know the specimen number or patient id. The manufacturer field service engineer (fse) confirmed the peptidase (pep) solenoid valve was defective. The fse replaced the peptidase solenoid valve and the system is fully operational. The possible cause of the reported reagent splashing and resulting in identification discrepancies was likely the defective peptidase reagent solenoid valve. No report of any further issues post repair of the instrument. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24797996]
It was reported that reagent drops were observed on the panels when removed from the walkaway plus instrument. One of the specimen on neg urine combo 51 panel resulted to high probability escherichia coli when it should have been acinetobacter. A second isolate from the same specimen was run and acinetobacter was obtained. The result of escherichia coli was not reported out of the laboratory. Another specimen also resulted to low probability identification. Identification not provided by the customer. However the result should have been acinetobacter based on visual observation of the plate. The results were edited prior to reporting. Customer technical support advised the customer to examine the dispense system. It was reported that the dispense head of the dispense system was dry and tubings appeared to be adjusted correctly. The customer tested each reagent valve and observed only drops of peptidase (pep) were being dispensed. The rest of the reagent valves were dispensing properly. There was no report of patient injury or change to patient treatment attributed with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2015-00106 |
| MDR Report Key | 5029653 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-25 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-07-27 |
| Date Mfgr Received | 2015-07-28 |
| Device Manufacturer Date | 2013-03-11 |
| Date Added to Maude | 2015-08-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NORMA RAHILL |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742139 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY 96 PLUS |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-08-25 |
| Model Number | N/A |
| Catalog Number | B1018-284 |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-25 |