MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-22 for ACCESS TESTOSTERONE, TOTAL 33560 manufactured by Beckman Coulter.
[142633277]
The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race. The access testosterone, total reagent was not returned for evaluation. All assay and system verifications met specifications at the time of this event. No hardware errors, flags or other assay issues were reported in conjunction with this event. The access testosterone, total result obtained on the access 2 immunoassay system was discordant with testosterone testing results obtained on a competitor instrument and the patient's clinical presentation. In conclusion, the root cause of this event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[142633278]
On (b)(6) 2019 the customer reported that on (b)(6) 2019 an elevated testosterone (access testosterone, total) result had been generated on the customer's access 2 analyzer (serial number (b)(4)) for one patient sample. The initial elevated access testosterone, total result of >0. 75 mg/ml was released from the laboratory. The customer reported administering medication to the patient in order to decrease the testosterone level; however, the details of what medication was administered was not provided. There was no additional change to or impact to patient care reported in association with this event. The customer reported retesting the sample on a competitor device and obtained a lower result. The customer did not provide the results or a reference range for the competitor device. Calibration was passing at the time of the event. System check was performed on (b)(6) 2019 and passed within specifications. No sample collection information such as sample type, sample tube type or size, centrifugation time or speed or any other sample processing information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2019-01071 |
| MDR Report Key | 8535856 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-02 |
| Date Facility Aware | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2018-08-31 |
| Date Added to Maude | 2019-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| 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 | 3 |
| Brand Name | ACCESS TESTOSTERONE, TOTAL |
| Generic Name | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Product Code | CDZ |
| Date Received | 2019-04-22 |
| Model Number | 33560 |
| Catalog Number | 33560 |
| Lot Number | 831937 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2019-04-22 |