MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-09 for ACCESS? TOTAL T4 ACCESS TT4 33800 manufactured by Beckman Coulter, Inc..
[2447232]
A customer reported to beckman coulter, inc. (bec) that unicel dxi 800 access immunoassay system generated a lower than expected total t4 (thyroxine) results for qc and patient samples. Access total t4 reagent lot 116012 received on (b)(6) 2011 was used for this test. It is unknown if the erroneous results were reported out of the laboratory. Subsequent testing on twenty eight (28) patient samples with a reagent of the same lot but received on a different date, (b)(6) 2011, produced higher results closer to the customer's expectation for 27 patient samples. A lower result was obtained for one patient sample. It is unknown if there was any change to patient treatment in connection to this event.
Patient Sequence No: 1, Text Type: D, B5
[9443618]
No specific sample information was provided. The customer calibrated with a new total t4 reagent lot, 116012. It was delivered on (b)(6) 2011. The calibrator in use was lot 119343 when the customer then noticed a qc shift low of approximately 10%. Patient results also shifted lower at this time. The customer then calibrated with the same reagent lot, from a shipment received on (b)(6) 2011, using the same calibrator. The customer repeated patients, but used reagent received on (b)(6) 2011. Qc and patient results improved slightly with this calibration, but were still lower than expected. The customer then ran patients and qc on the reagent that was received on (b)(6) 2011. This improved qc and patient results to within the customer's expected values. Service was not dispatched for this event. No definitive root cause was determined for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-06321 |
| MDR Report Key | 2365171 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-09 |
| Date of Report | 2011-11-10 |
| Date of Event | 2011-11-03 |
| Date Mfgr Received | 2011-11-10 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-23 |
| 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 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? TOTAL T4 |
| Generic Name | ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE |
| Product Code | KLI |
| Date Received | 2011-12-09 |
| Model Number | ACCESS TT4 |
| Catalog Number | 33800 |
| Lot Number | 116012 |
| Device Expiration Date | 2012-05-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-12-09 |