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 2013-08-15 for ACCESS? THYROGLOBULIN 33860 manufactured by Beckman Coulter.
[11013641]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[17838176]
The affiliate stated the customer reported reproducible and elevated thyroglobulin (tg) results, for one patient, involving the access thyroglobulin assay used in conjunction with the unicel dxi 800 access immunoassay system. The patient was tested four times for tg on the same unicel dxi 800 system. All results were comprised between 2 and 3 ng/ml and were discordant with two alternate methodologies. The elevated results were released out of the laboratory. The customer stated due to the high risk of relapse, the patient received a second dose of iodine-131 based on the elevated results. It is unknown if any additional treatment was given to the patient. There has been no report of current patient outcome. The patient? S samples were sent to beckman coulter customer product line support (cpls) laboratory for further analysis.
Patient Sequence No: 1, Text Type: D, B5
[18076862]
There is no indication the access thyroglobulin device was returned for evaluation. Testing at beckman coulter customer product line support (cpls) laboratory confirmed the presence of interfering substances in the patient's sample. In conclusion, patient sample interference is the root cause of the falsely elevated thyroglobulin (tg) results. Per product labeling: for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e. G. Human anti-mouse antibodies (hama), that interfere with immunoassays. Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples. Such interfering antibodies may cause erroneous results. Carefully evaluate the results of patients suspected of having these antibodies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00714 |
| MDR Report Key | 3290971 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-15 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-04-04 |
| Date Mfgr Received | 2013-07-23 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2013-08-16 |
| 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 | 2013-08-15 |
| Model Number | NA |
| Catalog Number | 33860 |
| Lot Number | 230159 |
| ID Number | NA |
| Device Expiration Date | 2015-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2013-08-15 |