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 2018-11-12 for ACCESS AFP ALPHA-FETOPROTEIN 33210 manufactured by Beckman Coulter.
[126896232]
The patients? Demographics such as age, date of birth, sex, weight, ethnicity and race were not supplied. The lot number of the reagent was not provided. Information on the expiration date, date of manufacture and udi cannot be determined. The access afp reagent was not returned for evaluation. The customer reported that quality control, calibration and system check were all performing within specifications. The access afp results of other samples and the results of all other tests were transmitted and received by the lis correctly. There were no hardware errors or issues with other results reported in conjunction with this event. The beckman coulter field service engineer (fse) and laboratory system support (lss) dispatched to the customer's site did not identify any hardware, software, reagent or system issues that would have contributed to this event. The fse was unable to reproduce this event. Re-transmission of the initial access afp result was sent and received with no errors. The cause of this isolated event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[126896233]
The customer contacted beckman coulter on (b)(6) 2018 to report elevated alpha-fetoprotein (access afp) results for one patient sample. The result was generated on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and recovered at 3. 45 ng/ml. The customer? S reference range is 0. 0? 13. 4 ng/ml. The customer? S laboratory information system (lis) recorded an elevated result of 345 ng/ml. The elevated access afp result was released from the lis and the report was sent to the patient. There was a change in patient care attributable to the elevated access afp result as the patient was admitted to a hospital and received treatment. The details of the treatment were not provided. The results of the testing in the hospital were reported to be normal. The customer did not report any additional change or impact to patient care or treatment in association with this event. The customer reported that quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event. Information on the collection and processing of the patient sample is not available. No issues with sample integrity were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2018-01031 |
| MDR Report Key | 8060137 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-12 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-09-15 |
| Date Facility Aware | 2018-10-19 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-12 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| 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 AFP ALPHA-FETOPROTEIN |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2018-11-12 |
| Catalog Number | 33210 |
| Lot Number | NOT PROVIDED |
| 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 | 1. Other | 2018-11-12 |