MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-02 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2328806]
The customer reported an elevated creatine kinase-mb (ck-mb) result, above the normal reference range, for one pt involving access 2 immunoassay system. This is report number one of two. The elevated result was reproducible, within the reference range, on the alleged access 2 system and on unicel dxi 800 access immunoassay system. The elevated result correlated with the pt's clinical condition and was released out of the laboratory. Subsequent samples from the pt produced results within the reference range. The pt was admitted to the hospital, but it is unk if any procedures were performed. There has been no report of pt injury or change in pt treatment associated with this event. The field service engineer (fse) was dispatched to access the unit.
Patient Sequence No: 1, Text Type: D, B5
[9455138]
The field service engineer (fse) serviced the unit on (b)(4) 2008. The fse examined hardware and verified alignments. The fse performed system verification and all system test results conformed to the manufacturer's performance published specifications. The pt's samples were collected in lithium heparin tubes without gel. The sample was centrifuged at 5,100 rpm (rotations per minute) for 5 minutes. Quality control (qc) is run every 24 hours, and the data indicates all levels were within +/-2 sd (standard deviation) of peer mean on the day of the event. A system check was performed on (b)(4) 2008, within specifications. This reportable event was identified during a retrospective review of product complaints conducted from 01/01/2008 through 10/23/2010 for additional reportable events. This medwatch report is related to mdr 2122870-2011-03451.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-03438 |
| MDR Report Key | 2245604 |
| Report Source | 05,06 |
| Date Received | 2011-09-02 |
| Date of Report | 2008-11-17 |
| Date of Event | 2008-11-14 |
| Date Mfgr Received | 2008-11-17 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2011-09-14 |
| 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 | ACCESS 2 IMMUNOASSAY SYSTEM |
| Product Code | JHS |
| Date Received | 2011-09-02 |
| Model Number | NA |
| Catalog Number | 81600N |
| 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 | 1. Hospitalization | 2011-09-02 |