MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,07 report with the FDA on 2011-05-02 for ACCESS THYROGLOBULIN ANTIBODY II A32898 manufactured by Beckman Coulter Inc..
[1851898]
This cf was opened to capture further evaluation of thyroglobulin antibody assay (thgaby) not meeting linearity specifications. In 2009, beckman coulter inc. , (bci) was performing internal dxi onboard dilution linearity studies for multiple assays. Wb ii, sample diluent a, and s0 calibrators were processed during this study to qualify wb ii as an additional assay diluent. Wb ii, sample diluent, and s0 calibrators did not meet the assay performance criteria linearity specifications. No patient results were generated in this event. Patient treatment was not affected.
Patient Sequence No: 1, Text Type: D, B5
[9044385]
This event will be further evaluated and investigated. Note: this reportable event was identified during a retrospective review on 04/01/2011 of complaints for additional reportable events. This cf is related to (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01239 |
| MDR Report Key | 2074294 |
| Report Source | 02,07 |
| Date Received | 2011-05-02 |
| Date of Report | 2009-12-01 |
| Date of Event | 2009-12-01 |
| Date Mfgr Received | 2009-12-01 |
| Date Added to Maude | 2012-02-23 |
| 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 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 THYROGLOBULIN ANTIBODY II |
| Generic Name | ACCESS THYROGLOBULIN ANTIBODY II |
| Product Code | JNL |
| Date Received | 2011-05-02 |
| Model Number | NA |
| Catalog Number | A32898 |
| Lot Number | 831065 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-05-02 |