MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-18 for DRIED POS COMBO TYPE 21 B1017-201 manufactured by Dade Behring, Inc..
[739030]
Single account reported to dade behring that they observed a clinical s. Aureus isolate oxacillin (ox) mic discrepancy. The account obtained oxacillin-susceptible results on the dried pos combo type 21 panel and oxacillin-resistant results on secondary methods that were also performed for the clinical isolate. Additionally, account reported that oxacillin resistance was confirmed by a reference laboratory. Results were reported. No report of injuries associated with the susceptible result being obtained.
Patient Sequence No: 1, Text Type: D, B5
[8040926]
Evaluation codes: method; routine monitoring of complaint history and performance trends to ensure performance is within claims. Results -clinical isolate received from the customer. Testing and evaluation are being performed. Conclusions - in house testing confirmed oxacillin susceptible result. The cause for the false susceptible result is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2007-00002 |
| MDR Report Key | 952538 |
| Report Source | 05 |
| Date Received | 2007-04-18 |
| Date of Report | 2007-04-18 |
| Date of Event | 2007-02-09 |
| Date Mfgr Received | 2007-03-30 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-11-26 |
| 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 | 0 |
| Manufacturer Contact | RICH LAGUNA |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743163 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIED POS COMBO TYPE 21 |
| Generic Name | ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. |
| Product Code | LTT |
| Date Received | 2007-04-18 |
| Model Number | NA |
| Catalog Number | B1017-201 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 923298 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-18 |