MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-30 for POSITIVE COMBO PANEL TYPE 33 B1017-211 manufactured by Siemens Healthcare Diagnostics.
[5120869]
It was reported tha organism identification discrepancies were noted between microscan positive combo panel type 33 and microscan rapid positive id panel type 2 isolates taken from the same bap purity plate were identified as high probability kocuria kristinae (96. 55%) and low probability staphylococcus lugdunensis (1. 52%) on microscan positive combo panel type 33 ((b)(4)) on both initial and repeat test. Another method was set up using microscan rapid positive id panel type 2 ((b)(4)) resulting in high probability staphylococcus lugdunensis (99. 99%) on both initial and repeat tests. The isolate was submitted to a reference laboratory for identification testing and resulted as high probability of staphylococcus lugdunensis. It is unknown what testing method was used by the reference laboratory to attain the organism id. The customer reported that the identification was previously finalized s coagulase negative staphylococcus species. Upon receipt of the results from the reference laboratory, the final identification was changed to staphylococcus lugdunensis and reported to the physician. There was no report of adverse event or injury associated with the discrepant results.
Patient Sequence No: 1, Text Type: D, B5
[12631008]
(b)(4): method - the customer sent the isolate to the reference lab for identification testing. Result - for use when no methods were performed and therefore no results will be obtained. The customer sent the isolate to the reference laboratory for identification testing and staphylococcus lugdunensis was obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00046 |
| MDR Report Key | 4385009 |
| Report Source | 05 |
| Date Received | 2014-12-30 |
| Date of Report | 2014-12-01 |
| Date of Event | 2014-11-27 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-01-20 |
| 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 | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSITIVE COMBO PANEL TYPE 33 |
| Generic Name | POSITIVE COMBO PANEL TYPE 33 |
| Product Code | LRG |
| Date Received | 2014-12-30 |
| Model Number | B1017-211 |
| Catalog Number | B1017-211 |
| Lot Number | 2015-07-18 |
| Device Expiration Date | 2015-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | WEST SACRAMENTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-30 |