MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-13 for NEG URINE COMBO 73 N/A B1017-423 manufactured by Beckman Coulter.
[5698114]
The manufacturer service support-(b)(4) assays department reported that there was an identification discrepancy when testing the (b)(6) 2015. The isolate was identified as leminorella on the walkaway (wa) 96 si instrument and shigella when read on the autoscan-4 (as-4) instrument. There was no patient involved as this was a proficiency survey isolate.
Patient Sequence No: 1, Text Type: D, B5
[13003942]
In addition, the cap survey isolate was tested on rapid neg id 3 (rnid3) panel, and rapid neg id 4 (rnid4) panel. The sample was also tested on an analytical profile index (api) strip as a reference test method. A high probability id shigella was attained on both of the rapid negative panels. On the api strip, a low probability id of shigella sp. Was attained. The cap survey final report has not been finalized for this isolate, the correct id of the specimen cannot be determined at this time. Please refer to medwatch report number 2919016-2015-00006 for a report of a similar event which occurred on (b)(6) 2015. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30231452]
The cap survey was received confirming the identification of the (b)(6) isolate as shigella boydii.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00007 |
| MDR Report Key | 4601657 |
| Report Source | 07 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-03-26 |
| Device Manufacturer Date | 2014-03-11 |
| Date Added to Maude | 2015-04-16 |
| 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 | 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEG URINE COMBO 73 |
| Generic Name | MICRO DILUTION PANEL |
| Product Code | LTT |
| Date Received | 2015-03-13 |
| Model Number | N/A |
| Catalog Number | B1017-423 |
| Lot Number | 2015-03-11 |
| Device Expiration Date | 2015-03-11 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-03-13 |