MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-08 for ACCESS? 2 IMMUNOASSAY ANALYZER ACCESS 2 81600 N manufactured by Beckman Coulter Inc..
[20382252]
Sample collection and centrifugation information have not been supplied to date. Per the customer, cmv-igg qc has been within the customer's established ranges. Specific qc data has not been supplied to date. Per the customer supplied documentation, a routine system check performed on (b)(6) 2011 passed within instrument specifications. Bec customer product line support (cpsl) testing of patient's sample indicate that sample was (b)(6) for cmv-igg. A clear root cause could not be determined for this event.
Patient Sequence No: 1, Text Type: N, H10
[20413490]
A customer contacted beckman coulter inc. (bec) to report obtaining a (b)(6) cytomegalovirus immunoglobulin g (cmv-igg) result for one (1) patient, generated by the access 2 immunoassay analyzer. The result was not reported out of the lab. Subsequent testing of the patient's sample on the same access 2 immunoassay analyzer generated a (b)(6) result. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected to this event. This report is related to mdr 2122870-2011-02141, where the same initial reporter reported to bec an erroneous (b)(6) cmv-igg, generated by the same access 2 immunoassay analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2011-02139 |
| MDR Report Key | 2154616 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-08 |
| Date of Report | 2011-06-10 |
| Date of Event | 2010-06-16 |
| Date Mfgr Received | 2011-06-10 |
| Device Manufacturer Date | 2004-08-16 |
| Date Added to Maude | 2011-09-20 |
| 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 | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? 2 IMMUNOASSAY ANALYZER |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE |
| Product Code | OMI |
| Date Received | 2011-07-08 |
| Model Number | ACCESS 2 |
| Catalog Number | 81600 N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-07-08 |