MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-09 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2199936]
The customer reported elevated creatine kinase-mb (ck-mb) results, above the normal reference range, for one pt involving unicel dxi 800 access immunoassay system. This is report number one of two referencing system serial number (b)(4). The pt's sample was retested and recovered a higher ck-mb result. The initial elevated result was released out of the lab and questioned by the nurse. There was no report of pt injury or change in pt treatment associated with this event. The field service engineer (fse) was dispatched to assess the unit.
Patient Sequence No: 1, Text Type: D, B5
[9470780]
The field service engineer (fse) serviced the unit on (b)(4) 2008. The fse noted the unit's sample probe failed carryover testing. The fse replaced the sample probe and successfully passed carryover testing. The fse performed and completed high sensitivity (hs) system check and quality control tests, which were within specifications. The fse completed repair verification, and the unit conformed to the mfr's performance specifications. The fse stated the customer is aware of pre-analytical sample handling that may have contributed to the event. The customer questioned proper sample handling standards by nursing staff since there is no direct control of pt samples. The pt's samples were collected in plastic green top heparin tubes with gel. Specimens were sampled from the primary tube. The samples were processed via the automation line and centrifuged for 6 minutes at 4,000 rpm (rotations per minute). This reportable event was identified during a retrospective review of product complaints conducted from january 01, 2008 through october 23, 2010 for add'l reportable events. This medwatch report is related to mdr: 2122870-2011-03486.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-03439 |
| MDR Report Key | 2253227 |
| Report Source | 05,06 |
| Date Received | 2011-09-09 |
| Date of Report | 2008-11-20 |
| Date of Event | 2008-11-08 |
| Date Mfgr Received | 2008-11-20 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2011-11-04 |
| 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. NORA ZEROUNIAN |
| 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 DR. |
| 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 |
| Product Code | JHS |
| Date Received | 2011-09-09 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID 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, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-09 |