MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-10 for ACCESS THYROGLOBULIN REAGENT 33860 manufactured by Beckman Coulter.
[6836990]
The customer reported obtaining reproducible elevated thyroglobulin (access thyroglobulin) results for one (1) patient involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)). The elevated access thyroglobulin results were discordant with the roche thyroglobulin result which was negative. Customer reported that the elevated thyroglobulin results were discordant with the patient clinical picture. The thyroid antibody (access thyroglobulin antibody ii) assay result for this patient was negative. The initial, elevated access thyroglobulin result was released from the laboratory. There was a report of a change in patient treatment associated with this event as the patient received radiology and nuclear medicine tests. System checks, quality controls (qc) and calibrations were performing within specifications at the time of the event. The patient's initial sample was collected in a seven (7) ml tube. The customer stated that the sample was centrifuged for ten (10) minutes at 3,500 rpm (revolutions per minute), at 32? C (celsius degree). There were no issues related to sample integrity reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[14200832]
Pt gender and weight: the customer did not supply patient's date of birth or weight. Initial reporter: customer account telephone number is (b)(6). \a beckman coulter (bec) field service engineer (fse) was not dispatched for this event. There is no evidence that the access thyroglobulin reagent was returned for evaluation. In conclusion, the cause of the event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[28483458]
The customer provided one sample for interference testing by the beckman coulter (bec) complaint handling unit (chu). The patient sample was analyzed on the access 2 immunoassay system serial number (b)(4), and recovered with an access thyroglobulin result of 72. 07 ng/ml. This result confirmed the result obtained by the customer. The access thyroglobulin normal reference range is 1. 15 - 50. 3 ng/ml. Interference testing, using a mix of different blockers, was performed. The blockers used in the interference testing consist of pool 1 (polymak 33, hbr-1) which is composed of animal derived antibodies and scavenger alp, a blocker related to alkaline phosphatase. The sample recovered above the assay reference range when tested with the scavenger alp with result of 75. 75 ng/ml. The result of the interference testing using the pool 1 of animal derived antibodies significantly reduced the result to within the assay reference range as it recovered at 2. 65 ng/ml. Per the thyroglobulin instructions for use (ifu) limitations of procedure: "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. Hama, that interfere with immunoassays. Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples. " in conclusion, the investigation demonstrated that heterophile interference which is listed in the access thyroglobulin limitations of procedure, is the cause of the falsely elevated thyroglobulin result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00426 |
| MDR Report Key | 4906234 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-10 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-04-17 |
| Date Mfgr Received | 2015-08-14 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-07-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS THYROGLOBULIN REAGENT |
| Generic Name | SYSTEM,TEST,THYROGLOBULIN |
| Product Code | MSW |
| Date Received | 2015-07-10 |
| Catalog Number | 33860 |
| Lot Number | 430265 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-10 |