MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-29 for ACCESS THYROXINE ASSAY CALIBRATOR 33805 manufactured by Beckman Coulter, Inc..
[18839394]
The customer reported that lower than expected total thyroxine (tt4) results were generated on an access 2 immunoassay system for an unknown quantity of patient samples over an unspecified number of days in association with a specific access thyroxine assay calibrator lot. The customer has not supplied the number of patients, dates of testing, or actual patient results to date. The tt4 results were questioned physicians. A correlation study performed between the customer site and an alternate site confirmed that the customer site was generating significantly lower tt4 results than the alternate site's laboratory. The customer did not receive any report of death, patient injury requiring medical intervention or change to patient treatment attributed or connected to this event. Sample collection/handling information was not provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[19043561]
Service was not dispatched to the site for this event. Beckman coulter inc. Assessment of customer supplied data indicated that instrument tt4 quality control results had been performing three to five standard deviations below the customer's established ranges since (b)(4) 2011. The customer was unaware of this, as the qc rules had not been set to alert for out of tt4 specification qc results. Beckman coulter inc. Assessment of customer supplied data revealed that the tt4 calibrator in use at the time of the event had been the subject of a customer notification letter addressing decreased tt4 calibrator stability. The customer was provided a new tt4 calibrator lot and performed the necessary calibration activities. A subsequent tt4 quality control assessment yielded results within the customer's established ranges after generating a new tt4 calibration curve. The customer indicated their intent to reassess previously reported tt4 patient results. The results of this assessment were not provided to beckman coulter inc. The root cause of the tt4 calibrator decreased stability is currently unknown and under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-04140 |
| MDR Report Key | 2269806 |
| Report Source | 05,06 |
| Date Received | 2011-09-29 |
| Date of Report | 2011-09-09 |
| Date of Event | 2011-09-08 |
| Date Mfgr Received | 2011-09-09 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2011-10-05 |
| 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 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-3027-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS THYROXINE ASSAY CALIBRATOR |
| Generic Name | ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE |
| Product Code | KLI |
| Date Received | 2011-09-29 |
| Model Number | NA |
| Catalog Number | 33805 |
| Lot Number | 019818 |
| ID Number | NA |
| Device Expiration Date | 2011-10-31 |
| 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 | 2011-09-29 |