MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-24 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2560383]
The customer reported elevated myoglobin results, above the normal reference interval, for three patients, involving access 2 immunoassay system. Subsequent testing on an alternate access 2 immunoassay system produced results within the normal reference interval for all three patients. The elevated results were released out of the laboratory. The customer stated one patient was admitted to the hospital due to the elevated result. There has been no report of patient outcome. The field service engineer (fse) assessed the unit at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9544538]
The field service engineer (fse) serviced the unit on (b)(4) 2011 and observed an issue with system fluidics. The fse traced the issue to a kinked wash buffer tubing located between the fluidics tray and the analyzer. The fse stated the fluidics tray was moved, causing the kink. The fse corrected the kink and verified system hardware by performing a passing system check within specifications. Quality control passed within the customer's established limits. The unit conformed to the manufacturer's published performance specifications. The customer stated there were no errors in the event log during the event and quality control (qc). All patient samples appeared to be slightly hemolyzed. All related medwatch reports: 2122870-2012-00186, 2122870-2012-00187, 2122870-2012-00188, 2122870-2012-00189, 2122870-2012-00190.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00185 |
| MDR Report Key | 2426951 |
| Report Source | 05,06 |
| Date Received | 2012-01-24 |
| Date of Report | 2011-12-25 |
| Date of Event | 2011-12-24 |
| Date Mfgr Received | 2011-12-25 |
| Device Manufacturer Date | 2004-03-23 |
| Date Added to Maude | 2012-01-25 |
| 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 |
| 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, 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 | ACCESS? 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | MVE |
| Date Received | 2012-01-24 |
| 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 DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-01-24 |