MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-09-16 for ACCESS VITAMIN B12 ASSAY 33000 manufactured by Beckman Coulter.
[4831628]
The affiliate stated the customer reported imprecision on four replicates on vitamin b12 involving the access vitamin b12 assay used in conjunction with the unicel dxi 800 access immunoassay system. The customer stated the results were released out of the laboratory. There was no report of patient impact associated with this event. The customer performed system diagnostics and noticed white powder on the analytical wheel. The customer indicated quality control (qc) was within specification prior to and following the event. Inspection of calibration, qc and other system check data, revealed no system issue. Service was requested and a beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[12351136]
There is no indication that the access vitamin b12 assay was returned for evaluation. The field service engineer (fse) inspected the system and did not observe any fluid leak. The fse removed and cleaned the wash wheel and verified the condition of the peristaltic pump tubing for the aspirate probes and the hydro drawer. The fse noted aspirate probe a2 had a rust-like residue at the tip and proactively replaced the aspirate probes. The fse completed system check and precision test. Service activity performed was verified to meet the specified requirements per established procedures. The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation. In conclusion, a definitive cause of the incident could not be determined with the available information. This medwatch report is related to mdr 8020879-2014-00009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2014-00654 |
| MDR Report Key | 4090991 |
| Report Source | 01,05,06 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-08-18 |
| Date of Event | 2014-08-18 |
| Date Mfgr Received | 2014-08-18 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-09-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 VITAMIN B12 ASSAY |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2014-09-16 |
| Model Number | NA |
| Catalog Number | 33000 |
| Lot Number | 424077 |
| ID Number | NA |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-16 |