MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-03 for ACCESS(R) THYROXINE ASSAY CALIBRATOR 33805 manufactured by Beckman Coulter, Inc..
[2296475]
The customer reported that on (b)(6) 2011 erroneous total thyroxine (tt4) results were generated on a unicel dxl800 access immunoassay system for multiple patients in association with the use of a specific access(r) thyroxine assay calibrator lot. The initial tt4 results were associated with access(r) thyroxine assay calibrator lot number 024072. Upon replacement of this calibrator lot with a new lot, a select number of the initial patient samples were retested and a 20-25% increase in dose value was noted. Beckman coulter inc. Assessment of customer supplied data indicates the involvement of twelve patient results. The initial results were either below or within the assay's normal reference range. Upon repeat testing of three patient samples after recalibration with a new calibrator lot, all three results were higher. The initial tt4 results were released from the laboratory; however, there were no reports of death, serious injury or modification to patient treatment associated or attributed to this event. Beckman coulter assessment of customer supplied instrument performance data indicated that quality control results recovered greater than two standard deviations below the mean value when utilizing the suspect calibrator lot. The tt4 samples were serum samples drawn in 13x100, yellow cap tubes. The customer indicated that the samples were tested in aliquot tubes. The customer could not verify if the samples were full draws.
Patient Sequence No: 1, Text Type: D, B5
[9388874]
A customer notification and replacement action was initiated by beckman coulter inc. For the suspect calibrator lot involved in this event. The root cause of the calibrator issue is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-05067 |
| MDR Report Key | 2322891 |
| Report Source | 05,06 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-10-14 |
| Date of Event | 2011-10-14 |
| Date Mfgr Received | 2011-10-14 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-07-11 |
| 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(R) THYROXINE ASSAY CALIBRATOR |
| Generic Name | ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE |
| Product Code | KLI |
| Date Received | 2011-11-03 |
| Model Number | NA |
| Catalog Number | 33805 |
| Lot Number | 024072 |
| ID Number | NA |
| Device Expiration Date | 2012-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-11-03 |