MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-27 for UNICEL? DXI 600 ACCESS? IMMUNOASSAY SYSTEM A30260 manufactured by Beckman Coulter, Inc..
[9889582]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[20221156]
Customer reported to beckman coulter, inc (bec) that the unicel dxi 600 access immunoassay system (dxi 600) generated an erroneous creatine kinase-mb (ck-mb) result. Customer reported that the erroneous result was not reported out of the laboratory. Customer reported that there was no injury or change in patient treatment. Customer reported that access ck-mb reagent kit (2 x 50 tests), lot 123055, and access ck-mb calibrators (s0-s5), lot 115362, were used in conjunction with the dxi 600 analyzer. There was no report of any adverse event or injury requiring medical intervention or patient treatment. Bec field service engineer (fse) performed preventive maintenance and verified instrument hardware. The fse did not find any malfunction in instrument hardware had occurred. The fse noted that the patient sample had red streaks in the gel, a red mass on top of the gel and a thickened serum colored substance floating at the top. The fse inquired about the condition of the sample. Customer reported that they believed the substance was fibrin and was to be expected because the patient sample had been run 14 hours earlier. The conditions the sample was stored in during the 14 hour time period is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2012-01396 |
| MDR Report Key | 2589552 |
| Report Source | 05,06 |
| Date Received | 2012-05-27 |
| Date of Report | 2012-05-02 |
| Date of Event | 2012-05-02 |
| Date Mfgr Received | 2012-05-02 |
| Device Manufacturer Date | 2008-03-26 |
| Date Added to Maude | 2012-09-25 |
| 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 |
| 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 | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| 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 600 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-05-27 |
| Model Number | NA |
| Catalog Number | A30260 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-05-27 |