MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-30 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[17144989]
A customer contacted beckman coulter inc. (bci) regarding a lower than expected result for inhibin a that was generated by the access 2 instrument for one pt. The initial inhibin a result was 25. 0pg/ml. The result was not reported out of the lab. The original sample was re-tested twice and results of 104. 7pg/ml and 102. 3pg/ml were obtained, respectively. The result of 102. 3pg/ml was reported out of the lab. There was no effect to pt treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[17318207]
The sample was collected in a serum tube and it was centrifuged at 3,500 rpm for 10 minutes. This is the only result and assay in question at this time. Qc was recovering within expected ranges prior to and on the day of event. A system check performed on 01/12/09 was within the published specifications. A field service engineer (fse) was dispatched: the fse replaced the transducer. The fse verified the repair per established procedures, and results met published performance specifications. Per fse, the transducer voltage was not holding at the correct reading while sonicating the particles while aspirating. It was intermittent which could explain why not all testing was affected. Also, not all assays are sensitive to sonicating problems. The fse stated this issue was the root cause for this event. Even though the low inhibin a result obtained is unlikely to be the basis to initiate or withhold treatment, in this event the hardware failure may have affected other pivotal assays. Erroneous results of a pivotal assay may contribute to serious injury to the pt. Hardware issue addressed by the fse likely contributed to this event. A malfunction will be assumed for the purpose of this report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2009-00035 |
| MDR Report Key | 1369584 |
| Report Source | 05 |
| Date Received | 2009-01-30 |
| Date of Report | 2009-01-30 |
| Date of Event | 2009-01-09 |
| Date Mfgr Received | 2009-01-13 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2010-01-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NORA ZEROUNIAN, GROUP MGR |
| Manufacturer Street | 200 S. KRAEMER BLVD. PO BOX 8000, MAIL STOP: W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | NDR |
| Date Received | 2009-01-30 |
| Model Number | ACCESS 2 IMMUNOASSAY SYSTEM |
| Catalog Number | 81600N |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-01-30 |