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 2018-10-10 for ACCESS AFP REAGENT 33211 manufactured by Beckman Coulter.
[123361374]
Patient demographics such as weight, race and ethnicity were not supplied. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance. The fse inspected the instrument's analytical module and removed and cleaned the wash wheel. Additionally, the sample probe was replaced as it appeared to be "slightly bent". Other proactive measures were taken to ensure instrument reliability including replacing the wash wheel bearings, the ejector plate sensor and the mixer motor. Lastly, the wash tower was cleaned and alignments adjusted/verified. The instrument's performance was verified through system check, hs (high sensitivity) system check, precision testing and carryover testing. All verification testing passed within published performance specifications. The fse did not note any hardware issues which would have contributed to this incident. The root cause of the low reproductive results (access inhibin a, access total bhcg ((5th is), access ue3 and access afp)) could not be determined with the information supplied.
Patient Sequence No: 1, Text Type: N, H10
[123361375]
The customer reported obtaining low reproductive testing results including inhibin a (access inhibin a), beta human chorionic gonadotropin (access total bhcg (5th is)), unconjugated estriol (access ue3) and alpha-fetoprotein (access afp) for one (1) patient involving the unicel dxi 800 access clinical system serial number (b)(4). The customer reanalyzed the patient's sample on the same unicel dxi 800 access clinical system two (2) additional times and obtained reproducible, higher results. The initial low results were released from the laboratory. The patient in question underwent an amniocentesis to rule out trisomy 18 due to the low results obtained. The results of that testing were normal. There was no additional injury or report of death associated with this incident. Quality control (qc) and calibrations were performing within the assay's specifications at the time of the incident. There were no error messages posted to the event log at the time of the event. The customer did not provide specific information regarding the collection of the patient's sample. Centrifugation time and speed were not supplied by the customer for this incident. No issues with sample integrity were reported by the customer. Service was requested by the customer and a beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2018-01020 |
| MDR Report Key | 7953973 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-08-27 |
| Date Facility Aware | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2018-10-10 |
| 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 AFP REAGENT |
| Generic Name | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER |
| Product Code | LOJ |
| Date Received | 2018-10-10 |
| Catalog Number | 33211 |
| Lot Number | 724409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-10 |