MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for ACCESS UNCONJUGATED ESTRIOL REAGENT 33570 manufactured by Beckman Coulter.
[30122445]
The customer did not provide patient demographics such as age, date of birth or weight. The access unconjugated estriol reagent was not returned for evaluation. All assay and system verifications met specifications. The cause of this event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[30122446]
The customer reported one (1) non-reproducibly elevated unconjugated estriol (access unconjugated estriol) result which was obtained on the laboratory's access 2 immunoassay system (serial number (b)(4)) for one (1) patient. The access unconjugated estriol was performed as part of a maternal serum triple screening test. The screening was performed on (b)(6) 2015 and an initial access unconjugated estriol result of 0. 5 nmol/l was obtained. The same sample was repeated as part of the laboratory's repeat protocol for access unconjugated estriol results of less than 1. 0 nmol/l and results of 5. 34 nmol/l and 0. 53 nmol/l were obtained. Per the customer, the lower access unconjugated estriol results were correct as the results met the clinical presentation of the patient. The results were not released from the laboratory. There were no reports of patient injury or change to patient treatment associated with this event. System parameters including calibration, quality control (qc) and system checks were within assay/instrument specifications. There were no errors posted in the event log. A precision run was performed using low control qc. The precision run met assay and system specifications. Alpha-fetoprotein (access afp) and human chorionic gonadotropin (access total bhcg (5th is)) tests were also performed as part of the maternal serum screening. Results for both assays were reproducible and not questioned. The sample was collected in a becton dickinson (bd) serum separator tube (sst) and was spun prior to arriving at the lab for testing. Sample processing information was not provided. The original serum tube was pulled and inspected. No issues with sample integrity were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2015-00699 |
| MDR Report Key | 5180711 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-02 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2015-10-02 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-10-27 |
| 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 | MR. JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681361 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCESS UNCONJUGATED ESTRIOL REAGENT |
| Generic Name | RADIOIMMUNOASSAY, ESTRIOL |
| Product Code | CGI |
| Date Received | 2015-10-27 |
| Model Number | NA |
| Catalog Number | 33570 |
| Lot Number | 437160 |
| Device Expiration Date | 2017-01-31 |
| 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 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-27 |