MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-02-07 for POS COMBO 29 PANEL TYPE N/A B1017-209 manufactured by Beckman Coulter.
[66763797]
The failure mode for the susceptibility discrepancy was likely due to the atypical nature of the isolate. Data provided by the customer and reviewed by beckman coulter did not indicate an instrument or panel issue. When tested on a panel containing the cefoxitin (cfxs) test, the resistance was detected and the isolate reported as (b)(6). Per clsi m07-a10, cefoxitin tests are better predictors of the presence of mec-mediated resistance than oxacillin test methods. In addition, the dried gram positive procedural manual (pn 3251-2419a) section f "reading the panels" states the following: for staphylococci with oxacillin, any growth should be considered significant. This s. Aureus isolate likely had heterogeneous expression of the meca gene, testing susceptible to oxacillin on the pc29 panel. The pc29 panel was unable to detect the (b)(6) with the oxacillin test alone. The customer followed clsi recommendations by performing offline tests in conjunction with the pc29 panel testing to ensure detection of the resistance. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[66763798]
The customer reported a (b)(6) result was obtained on pos combo 29 (pc29) panel type (lot number not provided) and the (b)(6) result was reported to the physician. The specimen was from a tissue source. The customer performed an etest and determined to be resistant (4ug/ml), verigene meca test was positive for meca, and the pbp2a test was (b)(6) for (b)(6) ). Customer stated the panel was not visually verified. An amended report was provided to the physician with (b)(6) identification. The attending nurse reported that the patient treatment was affected based on the amended report. There was no report of death or injury in connection with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2017-00001 |
| MDR Report Key | 6309139 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-09 |
| Date of Event | 2017-01-04 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-02-07 |
| 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 | 3 |
| Manufacturer Contact | ELIZABETH CHURCH |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742457 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POS COMBO 29 PANEL TYPE |
| Generic Name | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS |
| Product Code | LTT |
| Date Received | 2017-02-07 |
| Model Number | N/A |
| Catalog Number | B1017-209 |
| Lot Number | NOT PROVIDED |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-07 |