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 2012-03-05 for ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER ESTRADIOL DET 33540 manufactured by Beckman Coulter Inc..
[2550734]
The customer contacted beckman coulter inc. (bec) to report higher than expected results for estradiol on two patients' samples when run on a different reagent lot. The samples were run on the unicel dxi 800 access immunoassay system. The results were not reported out of the laboratory; hence no report of death or injury to patient or change to treatment is attributed to this event. Sample information was not provided. Per customer, the qc was acceptable prior to and after the event. Device name: unicel dxi 800 access immunoassay system; classification code: jje; 510k: k023764.
Patient Sequence No: 1, Text Type: D, B5
[9651992]
Service was not dispatched for this event. The sample was shipped to customer product line support (cpls) east for additional testing. Cpls testing results are pending.
Patient Sequence No: 1, Text Type: N, H10
[18805618]
From:date patient/sample access tsh results repeat access estradiol reagent lot 110598 reagent lot 117695(b)(6) 2012 1/1 4 110(b)(6) 2012 1/1 5 117(b)(6) 2012 2/1 17 57unit of measure (pg/ml)to:date patient/sample access tsh results repeat access estradiol reagent lot 110598 reagent lot 117695(b)(6) 2012 1/1 110 4(b)(6) 2012 1/1 117 5(b)(6) 2012 2/1 17 57unit of measure (pg/ml). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[18976006]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2012-00456 |
| MDR Report Key | 2477035 |
| Report Source | 01,05,06 |
| Date Received | 2012-03-05 |
| Date of Report | 2012-02-07 |
| Date of Event | 2012-01-31 |
| Date Mfgr Received | 2012-02-07 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-08-23 |
| 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 | MRS. 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
| Generic Name | CALIBRATOR, PRIMARY |
| Product Code | JIS |
| Date Received | 2012-03-05 |
| Model Number | ESTRADIOL DET |
| Catalog Number | 33540 |
| Lot Number | 117695 |
| ID Number | N/A |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-03-05 |