MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-19 for ACCESS TOTAL T4 CALIBRATOR 33805 manufactured by Beckman Coulter, Inc..
[2566506]
The customer reported ongoing unexpectedly low (b)(4) quality control (qc) results, patient results and (b)(4) results. The customer indicated that this issue had been occurring for approximately one month. No actual patient results were provided by the customer so it is unknown as to the actual duration, or number of patients involved, with this event. The customer was utilizing access total t4 calibrator lot 021654 during the timeframe of the event and had calibrated the instrument assay a minimum of two times ((b)(6) 2011 and (b)(6) 2011) using this calibrator lot. Patient results associated with access total t4 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, however there were no reports of adverse event, serious injury or modification to patient management associated or attributed to this event. Beckman coulter inc. Assessment of customer supplied instrument assay performance data indicated that all three levels of tt4 qc had been performing within the customer's established ranges, however further review of qc data indicated that for the past month, all three levels of tt4 qc values had been recovering between one to two standard deviations below the established mean. Routine system checks had been passing within instrument specifications. Beckman coulter inc. Assessment of customer supplied cap survey results indicated three out of the five specimens analyzed failed as "unacceptable" due to the values being below the "lower limits of acceptability. " no patient information, actual patient results or sample related information was provided for this event.
Patient Sequence No: 1, Text Type: D, B5
[9582679]
Service was not dispatched to the site for this event. Access total t4 calibrator 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 previously issued by beckman coulter inc. A new calibrator lot was issued to the customer and beckman coulter inc. Customer technical support followed up with the customer on (b)(6) 2012. The customer stated that after re-calibration using the new tt4 calibrator lot, the assay quality control recovery was much better and all of the cap survey samples resulted within the provided ranges.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00085 |
| MDR Report Key | 2420931 |
| Report Source | 05,06 |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-28 |
| Date of Event | 2011-12-27 |
| Date Mfgr Received | 2011-12-28 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-05-21 |
| 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 | 2012-01-19 |
| 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 | 2012-01-19 |