MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-24 for DRIED POS MIC PANEL TYPE 20A B1017-203A manufactured by Dade Behring, Inc..
[16470371]
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 a secondary method (kirby bauer) also performed for the clinical isolate. There was no report of adverse health consequences to the patient as a result of the false susceptible results being obtained and reported to the doctor.
Patient Sequence No: 1, Text Type: D, B5
[16647237]
Evaluation method; other - contacted customer to obtain clinical isolate for evaluation. Routine monitoring of complaint history and performance trends to ensure performance is within claims. Evaluation results: clinical isolate has not been received from the customer. In-house testing of the isolate is anticipated, but not yet performed. Conclusions: overall oxacillin performance of dried pos panels is acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2006-00013 |
| MDR Report Key | 745531 |
| Report Source | 05 |
| Date Received | 2006-07-24 |
| Date of Report | 2006-06-30 |
| Date of Event | 2006-06-26 |
| Date Mfgr Received | 2006-06-30 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-08-10 |
| 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 | 2006-07-24 |
| Model Number | NA |
| Catalog Number | B1017-203A |
| Lot Number | 2007-04-06 |
| ID Number | NA |
| Device Expiration Date | 2007-04-06 |
| 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 | 733306 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-24 |