MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-10 for DRIED POS COMBO TYPE 20 B1017-200 manufactured by Siemens Healthcare Diagnostics Inc.,.
[19000459]
Evaluation codes: method; routine monitoring of complaint history and performance trends to ensure performance is within claims. Evaluation codes: results; requested additional information to determine if malfunction occurred. Evaluation codes: conclusions; product is within performance claims. The cause of the oxacillin susceptible results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[19051189]
Customer reported five s. Aureus isolates oxacillin (ox) mic discrepancy. They obtained oxacillin- susceptible results on the dried pos combo type 20 panel and oxacillin-resistant results on secondary methods that were also performed for the clinical isolate. Results were not reported to the physician. No reports of adverse health consequences associated with the discrepant result being obtained. The cause of the oxacillin susceptible results is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2008-00002 |
| MDR Report Key | 977956 |
| Report Source | 05 |
| Date Received | 2008-01-10 |
| Date of Report | 2007-01-04 |
| Date of Event | 2007-12-27 |
| Date Mfgr Received | 2007-12-14 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2009-12-29 |
| 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 | RICH LAGUNA |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743163 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIED POS COMBO TYPE 20 |
| Generic Name | ANTIMICROBIC SUSCEPT. PANEL: GRAM POS |
| Product Code | LTT |
| Date Received | 2008-01-10 |
| Model Number | NA |
| Catalog Number | B1017-200 |
| Lot Number | 2008-09-27 |
| ID Number | NA |
| Device Expiration Date | 2008-09-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC., |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-10 |