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 2018-11-29 for ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER 33560 manufactured by Chaska Discrete Mfg Io.
[128732256]
The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity, and race. The testosterone reagent was not returned for evaluation. A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site. No hardware errors, flags or other assay issues were reported in conjunction with this incident. Customer technical support completed troubleshooting and hardware verification with the customer via phone. Testosterone precision runs were requested and recovered within precision claim. The cause of this event could not be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[128732257]
The customer reported obtaining non-reproducible estradiol, tsh, free t3, and testosterone patient results involving the laboratory's access 2 immunoassay analyzer (serial number (b)(4)). There was a change to treatment for one patient based on a testosterone result. The patient had a change in injection amount. There was no reported injury or illness to the patient in this event. Quality control (qc) recovered outside customer? S established ranges for multiple assays. The customer recalibrated and/or used fresh qc and recovered within range. No issues with sample integrity were reported by the customer for this initial sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2018-01033 |
| MDR Report Key | 8114858 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-11-29 |
| 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 | MR DAVID DAVIS |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer G1 | CHASKA DISCRETE MFG IO |
| 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 | 3 |
| Brand Name | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2018-11-29 |
| Model Number | 33560 |
| Catalog Number | 33560 |
| Lot Number | 724425 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHASKA DISCRETE MFG IO |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-29 |