MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-30 for DRIED POS MIC PANEL TYPE 20A B1017-203A manufactured by Dade Behring, Inc..
[519491]
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 mic panel type 20a panel and oxacillin-resistant results on secondary methods that were also performed for the clinical isolate. Operator took action when multiple offline tests did not match mic result. Results were reported based on offline tests. No report of injury associated with this result being obtained.
Patient Sequence No: 1, Text Type: D, B5
[7982078]
Evaluation codes: contacted customer to obtain clinical isolate for evaluation. Routine monitoring of complaint history and performance trends to ensure performance is within claims. Clinical isolate has not been received from the customer. In-house testing performed. Conclusion: in house testing for the account provided isolate confirmed on dried overnight panels an oxacillin susceptible result. Frozen reference panel and growth on the ox screen plate confirms ox resistance. Overall oxacillin performance of dried pos panels is acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2006-00015 |
| MDR Report Key | 774560 |
| Report Source | 05 |
| Date Received | 2006-08-30 |
| Date of Report | 2006-08-05 |
| Date of Event | 2006-08-02 |
| Date Mfgr Received | 2006-08-05 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2006-11-01 |
| 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 | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743285 |
| 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 MIC PANEL TYPE 20A |
| Generic Name | ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. |
| Product Code | LTT |
| Date Received | 2006-08-30 |
| Model Number | NA |
| Catalog Number | B1017-203A |
| Lot Number | 2007-06-22 |
| ID Number | NA |
| Device Expiration Date | 2007-06-22 |
| 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 | 762342 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US |
| Baseline Brand Name | MICROSCAN |
| Baseline Generic Name | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL |
| Baseline Catalog No | B1017-203A |
| Baseline Device Family | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL: DRIED GRAM POS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K862140 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-30 |