MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-24 for UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM N/A A71461 manufactured by Beckman Coulter, Inc..
[15509043]
On (b)(6) 2012 customer reported that the dxi 600 instrument generated an erroneously elevated ck-mb result for one patient. The result obtained of 5. 2 ng/ml was above the normal reference range. Customer stated that two additional samples were analyzed and ck-mb results were within the normal reference range (3. 0 ng/ml on (b)(6) 2012 and 2. 4 ng/ml on (b)(6) 2012). The customer was uncertain if there was any change to patient treatment as a result of the elevated result. There was no quality control, calibration, system check, or patient data supplied by the customer for review. Multiple attempts were made to obtain additional information, but this was the only information supplied by the customer regarding this event. The failure mode for this event is unknown and could not be determined using the supplied data.
Patient Sequence No: 1, Text Type: D, B5
[15530161]
Device evaluated by manufacturer, no: customer did not supply information regarding this event. No data supplied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01516 |
| MDR Report Key | 2626917 |
| Report Source | 05,06 |
| Date Received | 2012-06-24 |
| Date of Report | 2012-05-31 |
| Date of Event | 2012-05-30 |
| Date Mfgr Received | 2012-05-31 |
| Device Manufacturer Date | 2011-04-19 |
| Date Added to Maude | 2012-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | 2012-06-24 |
| Model Number | N/A |
| Catalog Number | A71461 |
| ID Number | SOFTWARE VERSION 4.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-24 |