MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-24 for ACCESS? THYROGLOBULIN 33860 manufactured by Beckman Coulter.
[19398634]
There is no indication the access thyroglobulin device was returned for evaluation. In conclusion, a definitive cause of the incident could not be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[19557766]
The customer reported positive thyroglobulin (access thyroglobulin) results involving the access thyroglobulin assay used in conjunction with the unicel dxi 800 access immunoassay system. Results were negative through an alternate methodology. The patient samples were also tested through mass spectrometry which also produced negative results and correlated with the patient's clinical picture. The original results were released from the laboratory. There was no patient injury or change in patient treatment associated with this event. The customer had validated the access thyroglobulin assay to perform at levels below those stated in the ifu (instructions for use). The customer also performed a correlation study. Within it, there were examples of recovery outside of the expected recovery per the ifu. Data analysis indicates that all measured system parameters had been within specifications. No system issues were reported. The instrument was in normal operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2013-01123 |
| MDR Report Key | 3537057 |
| Report Source | 05,06 |
| Date Received | 2013-12-24 |
| Date of Report | 2013-12-02 |
| Date of Event | 2013-12-02 |
| Date Mfgr Received | 2013-12-02 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-04-02 |
| 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 |
| 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? THYROGLOBULIN |
| Generic Name | SYSTEM,TEST,THYROGLOBULIN |
| Product Code | MSW |
| Date Received | 2013-12-24 |
| Model Number | NA |
| Catalog Number | 33860 |
| Lot Number | 330925 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-24 |