MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-27 for ACCESS? 2 IMMUNOASSAY SYSTEM TOTAL T4 REAGENT 81600N manufactured by Beckman Coulter Inc..
[17410702]
A beckman coulter inc (bec) (b)(4) study was performed to verify the dilution claim of 100 +/- 10% for the total t4 assay on 15 patients. The samples were diluted 1:2 using the diluent recommended in the instructions for use, s0 calibrator. 7 samples recovered >110%, not meeting the dilution recovery claim of the assay. As this was an internal study, there was no risk of patient injury requiring medical intervention or change to patient treatment attributed or connected to this event. However, in a similar situation, the potential of such risk does exist. The samples were freshly drawn in a plain red serum tube and were tested neat and diluted within 4 hours of collection. Qc had been performed and recovered within range on the date of testing. The system was up to date on daily and weekly maintenance. Service was not dispatched.
Patient Sequence No: 1, Text Type: D, B5
[17817255]
.
Patient Sequence No: 1, Text Type: N, H10
[19527362]
.
Patient Sequence No: 1, Text Type: D, B5
[19648782]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-05043 |
| MDR Report Key | 2312039 |
| Report Source | 07 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-09-02 |
| Date Mfgr Received | 2011-09-02 |
| Date Added to Maude | 2012-07-10 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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? 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | KLI |
| Date Received | 2011-10-27 |
| Model Number | TOTAL T4 REAGENT |
| Catalog Number | 81600N |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2011-10-27 |