MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-17 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter.
[15425606]
The customer reported erroneous creatine kinase-mb (ck-mb) results for several patients and reagent dispense, pipettor motion and quantity not sufficient (qns) system errors with multiple quality control (qc) recovering outside specifications, involving the unicel dxi 800 access immunoassay system. The customer stated initial results of 0. 00 ng/ml were obtained. The customer reanalyzed the patients? Samples, on an alternate instrument, and recovered higher results of 0. 5 ng/ml. No errors were noted in the event log. The erroneous results were not released out of the laboratory. There was no report of patient consequence or change in patient treatment associated with this event. A beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[15598149]
The field service engineer (fse) discovered the sample probe tubing was leaking at the fitting and replaced the sample probe and performed alignments. The fse identified a fluid leak in the tubing to reagent pipettor #3, due to repetitive contact with the motor and replaced the reagent pipettor tubing and quick disconnect fitting, then completed ultrasonics adjustment and pressure sensor calibration. The fse completed system check, and it passed within specifications. The fse verified carryover and quality control (qc) were within specifications. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00550 |
| MDR Report Key | 3173212 |
| Report Source | 05,06 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-05-18 |
| Date of Event | 2013-05-18 |
| Date Mfgr Received | 2013-05-18 |
| Device Manufacturer Date | 2008-06-18 |
| Date Added to Maude | 2013-09-11 |
| 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 | UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-06-17 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-06-17 |