MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for ACCESS DIGOXIN REAGENT 33710 manufactured by Beckman Coulter.
[89626992]
The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity, and race. The access digoxin reagent was not returned for evaluation. A beckman coulter field service engineer (fse) was dispatched to the customer's laboratory to evaluate the performance of the instrument. The fse performed preventative maintenance. There was no report of a system performance issue that would have contributed to this event. In conclusion. An assignable cause for this event could not be determined with the information provided. There is no evidence to reasonably suggest a system malfunction; system parameters (system checks, level sense diagnostic testing, qc) met assay and instrument specifications.
Patient Sequence No: 1, Text Type: N, H10
[89626993]
The customer reported obtaining non-reproducible digoxin (access digoxin) results on the laboratory's access 2 immunoassay system (serial number (b)(4)) for one patient. The patient's sample was analyzed in triplicate and recovered with imprecise access digoxin results. These results were not released from the laboratory. There was no impact or change to patient care or treatment in association with the non-reproducible access digoxin results. Quality control (qc) was recovering within specifications prior to the event. The customer reported that qc was out of specifications the day following this event. The patient's sample was collected in a plasma separation tube. The customer was not able to provide centrifuge information such as speed, time or temperature. No issues with sample integrity were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2017-00050 |
| MDR Report Key | 6908255 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-11 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2017-10-02 |
| 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 | ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCESS DIGOXIN REAGENT |
| Generic Name | ENZYME IMMUNOASSAY, DIGOXIN |
| Product Code | KXT |
| Date Received | 2017-10-02 |
| Model Number | 33710 |
| Catalog Number | 33710 |
| Lot Number | 633010 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-02 |