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 2016-07-27 for POS COMBO PANEL TYPE 34 N/A B1017-214 manufactured by Beckman Coulter Inc.
[50910524]
The customer provided panel data for the repeat panel tested on 06/30/2016 was reviewed by beckman national product support team. Data indicated linezolid (lzd) mic = 4 (susceptible). Processed data indicated heavy growth in the 1 and 2 wells and very light growth in the 4 well, however not enough to achieve the threshold. The data did not indicate any hardware, product, or set up issues. The same isolate was sent to beckman coulter for testing. Beckman technical support lab (tsl) noted on the growth plates that there appeared to be two different colony types. The isolate was set up multiple times on pos combo panel type 34 (pc34) panels lot 2017-01-22 and on frozen reference panels, manufactured following clsi recommendations. Linezolid results were inconsistent, with the isolate testing as lzd susceptible and resistant on multiple frozen reference panels and pc34 panels. The failure mode for the false susceptible linezolid interpretation could not be conclusively determined with the information available. The testing indicates a possible mixed culture or atypical isolate (potentially with variable plasmid-mediated resistance) which could be contributing to the discrepant results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[50910565]
The customer reported a false susceptible linezoid (lzd) result was obtained on pos combo panel type 34 lot 2017-01-22 for a staphylococcus capitis isolate. The isolate was a (b)(6). (b)(6) expected a resistant lzd interpretation for the isolate. The customer initial test of the isolate on (b)(6) 2016 obtained the correct identification of staphylococcus capitis and the lzd mic was 4 (susceptible). Repeat test of the same isolate performed on (b)(6) 2016 obtained the same results. The customer stated they used prompt method for both panel set-ups. The panels were visually verified by the customer and the customer agreed with the instrument reads. Customer confirmed panel qc and instrument diagnostics were all in range for both weeks the (b)(6) isolate was tested. There was no patient involved as this was a proficiency survey isolate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2016-00005 |
| MDR Report Key | 5828313 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-27 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-05-26 |
| Date Mfgr Received | 2016-06-30 |
| Device Manufacturer Date | 2016-01-22 |
| Date Added to Maude | 2016-07-27 |
| 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 | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742457 |
| Manufacturer G1 | BECKMAN COULTER INC |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POS COMBO PANEL TYPE 34 |
| Generic Name | MICRO DILUTION PANEL |
| Product Code | LTT |
| Date Received | 2016-07-27 |
| Model Number | N/A |
| Catalog Number | B1017-214 |
| Lot Number | 2017-01-22 |
| Device Expiration Date | 2017-01-22 |
| 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 INC |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-27 |