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 2017-02-22 for POS COMBO 29 PANEL TYPE N/A B1017-209 manufactured by Beckman Coulter.
[68035578]
The failure mode for the misidentification could not be conclusively determined with the information available. The available information does not reasonably suggest that the pos combo 29 (pc29) panel (lot number not provided) has malfunctioned. Customer panel data was reviewed with no instrument or panel issue indicated. The customer did not perform repeat testing of the isolate on the pc29 panel and the isolate was no longer available for additional troubleshooting. Data review indicated set-up issue (i. E over-inoculation) may have contributed to the reported discrepancy. Beckman coulter internal identifier for this report is (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[68035579]
The customer reported a misidentification of (b)(6) as (b)(6), on pos combo 29 panel type, lot unknown. The customer performed offline test methods which indicated the isolate was (b)(6). Staphaurex test was positive, pbp2 test was negative, verigene test indicated (b)(6) positive, and reference laboratory reported as (b)(6) (ox>2). During a follow up call on (b)(6) 2017, customer stated the isolate was originally reported as (b)(6), but an amended report was sent to the physician with the correct identification (id) of (b)(6). Per the physician, patient treatment was affected with the change in id however the customer could not provide additional details. Customer stated the patient had been discharged but it was unknown if patient was discharged prior to the amended report. Retest of the isolate is not possible as it was no longer available. There was no report of death or injury in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2017-00003 |
| MDR Report Key | 6349802 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-22 |
| Date of Report | 2017-01-27 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-01-27 |
| Date Added to Maude | 2017-02-22 |
| 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 SACRMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742457 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTEPRISE 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 | 2017-02-22 |
| 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 | 2017-02-22 |