MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-27 for POWERCEL POWER PROCESSOR A36587 manufactured by Beckman Coulter, Inc..
[1751109]
A customer contacted beckman coulter inc. (bci) in regards to increased number of false positive hepatitis b virus surface antigen (hbsag) results obtained from unicel dxi 800 access immunoassay analyzer after having the analyzer connected to powercel power processor. No patient treatment was affected because all positive results were run on confirmatory tests.
Patient Sequence No: 1, Text Type: D, B5
[8742692]
The customer is using sst ii plastic tubes. The samples were spun at 1960g for 10 minutes. No information regarding patients and the system was provided. Service information was requested, but was not supplied. The root cause for the event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01077 |
| MDR Report Key | 1884347 |
| Report Source | 05 |
| Date Received | 2010-10-27 |
| Date of Report | 2010-10-27 |
| Date of Event | 2010-09-01 |
| Date Mfgr Received | 2010-09-30 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-01-10 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERCEL POWER PROCESSOR |
| Generic Name | SAMPLE PROCESSING SYSTEM |
| Product Code | JJI |
| Date Received | 2010-10-27 |
| Model Number | NA |
| Catalog Number | A36587 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2010-10-27 |