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..
[2297822]
The customer reported that on 10/13/2011 erroneous total thyroxine (tt4) results were generated on a unicel dxi800 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 021654. Although no repeat confirmatory testing was performed on the tt4 results they were regarded as suspect because they did not agree with same-sample free total thyroxine and thyroid stimulating hormone results for the patients, which were considered "normal. " beckman coulter inc. Assessment of customer supplied data indicates the involvement of five patient results. The initial tt4 results were below the assay's normal reference range. The initial tt4 results were released from the laboratory; however, they were question by the physician as being "slightly depressed" as they did not fall within the normal reference range of the assay, while other thyroid assays test results appeared normal. There were no reports of death, serious injury or modification to patient treatment associated or attributed to this event. Tt4 quality control results recovered one to two standard deviations below the mean value when utilizing the suspect calibrator lot. No patient demographic or sample collection/handling information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[9383229]
A replacement tt4 calibrator lot was sent to the customer. The customer was able to recalibrate the assay, and after doing so, quality control results performed within established ranges. The customer indicated that they were satisfied with assay dose recovery after calibrating with the new calibrator lot. 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 | 2122870-2011-05068 |
| MDR Report Key | 2323100 |
| Report Source | 05,06 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-10-14 |
| Date of Event | 2011-10-13 |
| Date Mfgr Received | 2011-10-14 |
| Device Manufacturer Date | 2010-11-01 |
| 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 | 021654 |
| ID Number | NA |
| Device Expiration Date | 2011-12-31 |
| 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 |