MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-10 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter Inc..
[1609850]
A customer contacted beckman coulter inc. , (bci) regarding erroneously low ckmb results generated by the access 2 immunoassay system for one patient. Upon repeat, the result was within the normal reference range. The low result was reported out of the lab. No reports of death, injury, or change to patient treatment have been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[8639861]
Sample is serum collected in a sst tube that was centrifuged at 5,000 rpm for 5 minutes. Qc was within the customer's established ranges prior to the event. A system check performed on (b)(6) 2010 met specifications. A field service engineer (fse) was dispatched: the fse inspected the instrument and no hardware issues were noted that would have contributed to this event. The fse performed system check and precision test with good results. No clear root cause could be determined for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00308 |
| MDR Report Key | 1751495 |
| Report Source | 05 |
| Date Received | 2010-07-10 |
| Date of Report | 2010-07-09 |
| Date of Event | 2010-06-15 |
| Date Mfgr Received | 2010-06-15 |
| Device Manufacturer Date | 2007-10-16 |
| Date Added to Maude | 2010-08-10 |
| 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 | 0 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2010-07-10 |
| Model Number | ACCESS? 2 IMMUNOASSAY SYSTEM |
| Catalog Number | 81600N |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-07-10 |