MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-20 for NEG BREAKPOINT COMBO 47 N/A B1017-417 manufactured by Beckman Coulter.
[5818490]
It was reported that the (b)(6) initial result using neg breakpoint combo 47 panel identified the isolate as leminorella sp. 93. 14%. Api strip was set up however it did not attain any high probability organism identification. Upon notification from (b)(6) of the incorrect result, repeat tests were performed by setting up three panels. One panel resulted in high probability of shigella species 99. 30%. The other two panels have the same identification of leminorella species as on initial testing.
Patient Sequence No: 1, Text Type: D, B5
[13396649]
The manufacturer participated in the same proficiency survey using (b)(6). When tested on conventional overnight panels and read on the wa instrument, an id of leminorella sp. 93. 14% was attained. When the same panel was read on the autoscan-4 (as-4) instrument, an id of shigella sp. 99. 30% was attained. The difference between the two reads was the cf8 (cephalothin 8 (ug/ml) well; the cf8 well was negative on the wa and positive on the as-4. It was noted that the cf8 well was a weak positive when visually verified. The results from the cf8 panel along with the panel results from the other biochemicals/antimicrobics are used to generate the biotype number for the organism tested and the corresponding identification. An id of shigella was also attained on two additional tests using rapid negative panels. Also, the sample was tested on an analytical profile index (api) strip as a reference test method and a low probability id of shigella sp. Was attained. It is possible that emerging resistance with this organism may be contributing to the identification discrepancy. Please refer to medwatch report number 2919016-2015-00058 for report of a similar event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00059 |
| MDR Report Key | 4785452 |
| Report Source | 05,06 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-04-24 |
| Date of Event | 2015-04-13 |
| Date Mfgr Received | 2015-04-24 |
| Device Manufacturer Date | 2015-02-27 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| Event Location | 0 |
| 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 | NEG BREAKPOINT COMBO 47 |
| Generic Name | MICRO DILUTION PANEL |
| Product Code | LRG |
| Date Received | 2015-05-20 |
| Model Number | N/A |
| Catalog Number | B1017-417 |
| Lot Number | 2016-02-27 |
| Device Expiration Date | 2016-02-27 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-05-20 |