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.
[66774281]
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. Per clsi m07-a10, cefoxitin tests are better predictors of the presence of mec-mediated resistance than (b)(6) test methods. In addition, the dried gram positive procedural manual (pn 3251-2419a) section f "reading the panels" states the following: for (b)(6), any growth should be considered significant. This s. Aureus isolate likely had heterogeneous expression of the meca gene, testing (b)(6) on the pc29 panel. The pc29 panel was unable to detect the resistance with the (b)(6) 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
[66774282]
The customer reported that the pos combo 29 (pc29) panel type (lot umber not provided) gave a (b)(6). Customer stated the panel was not visually verified. The specimen was from a tissue source. The (b)(6) result was provided to the physician. Offline testing methods indicated the isolate was (b)(6). An amended report was provided to the physician with mrsa identification. The physician reported the patient treatment was going to be changed based on the amended report however no further details were provided. During a follow up call with the customer on (b)(6) 2017, the customer reported the patient had been released from the hospital. There was no report of death or injury in connection with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2017-00002 |
| MDR Report Key | 6309143 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-10 |
| Date of Event | 2017-01-04 |
| Date Mfgr Received | 2017-01-10 |
| 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 |