MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-19 for ACCESS TOTAL T4 CALIBRATOR 33805 manufactured by Beckman Coulter, Inc..
[2501600]
The customer reported on (b)(6) 2011 all five total t4 (tt4) college of american pathologists survey results failed to meet specification. The customer was using tt4 calibrator lot 021654. The customer was advised to discontinue use of the calibrator lot. It is unknown as to whether any patient results were affected by this event, or correspondingly whether subsequent patient treatment was modified. It is also unknown as to whether a death or serous injury was associated with this event. No system or sample related information was provided for this event.
Patient Sequence No: 1, Text Type: D, B5
[9563935]
Service was not dispatched to the site for this event. Through beckman coulter inc. Investigation it was identified that the tt4 calibrator lot involved with this event was identified as the root cause for falsely decreased total t4 patient or quality control results of up to two standard deviations or more. This is a known issue for which customer notification was generated and provided to this customer by beckman coulter inc. Beckman coulter inc. Records indicate that this customer did not return the associated notification faxback form to date. The tt4 calibrator lot was the root cause of this event's low cap results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-06496 |
| MDR Report Key | 2381783 |
| Report Source | 05,06 |
| Date Received | 2011-12-19 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-10-18 |
| Date Mfgr Received | 2011-12-02 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-07-24 |
| 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 | 2011-12-19 |
| 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 | 2011-12-19 |