MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-03 for ACCESS TOTAL T4 CALIBRATOR 33805 manufactured by Beckman Coulter, Inc..
[2330388]
The customer reported on (b)(6) 2011 total t4 (tt4) quality control (qc) results failed to meet customer established specifications. The qc shift to unacceptable results coincided with transition from calibrator lot 021654 to calibrator lot 120301. Patient results using calibrator lot 021654 were reported out of the laboratory. The quantity, actual results and event dates associated with previously reported patient results associated with total t4 (tt4) calibrator lot 021654 is unknown. While there were no reports of adverse event or serious injury related to this event, it is unknown as to whether there was a change to patient management. No patient information, actual patient results or sample related information was provided for this event. No additional system information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[9597078]
Service was not dispatched to the site for this event. Through beckman coulter inc. Investigation it was identified that calibrator lot 120301 was expected to demonstrate a shift up in quality control and patient recovery of approximately two to fourteen percent. This lot met all internal specifications prior to release and was within the normal assay variability. The other tt4 calibrator lot associated with this event (lot 021654) was identified as the root cause for falsely decreased total t4 patient or quality control results of up to two standard deviations or more in a previous beckman coulter inc. Investigation. This is a known issue for which customer notification was generated, provided and discussed with this customer by beckman coulter inc. Beckman coulter inc. Records indicate that the customer had not returned the associated notification faxback form to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00006 |
| MDR Report Key | 2395851 |
| Report Source | 05,06 |
| Date Received | 2012-01-03 |
| Date of Report | 2011-12-14 |
| Date of Event | 2011-12-13 |
| Date Mfgr Received | 2011-12-14 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-3027-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS TOTAL T4 CALIBRATOR |
| Generic Name | ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE |
| Product Code | KLI |
| Date Received | 2012-01-03 |
| Model Number | NA |
| Catalog Number | 33805 |
| Lot Number | 021654 |
| ID Number | NA |
| Device Expiration Date | 2011-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-01-03 |