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 2015-05-12 for ACCESS THYROGLOBULIN ANTIBODY II REAGENT A32898 manufactured by Beckman Coulter.
[21180185]
The customer reported obtaining a normal thyroglobulin antibody (access thyroglobulin antibody ii) result for one (1) patient on the unicel dxi 800 access immunoassay system (serial number (b)(4)) that was discordant to two (2) other methodologies. The customer analyzed the patient's sample on an alternate methodology (roche) and obtained a discordant, higher result above the assay's normal reference range. The customer also analyzed the patient's sample on a second methodology (siemens) and again obtained a discordant, higher result above the assay's normal reference range. The access thyroglobulin antibody ii result was not reported outside the laboratory. There was no report of patient injury or change in patient treatment associated with this event. Assay calibration was performing within published specifications. Qc (quality control) and system check data was not supplied by the customer. The customer did not supply information regarding sample collection such as tube type. The patient's sample was centrifuged for ten (10) minutes at 3,000 rpm (revolutions per minute) at room temperature. There was no report of sample integrity issues reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[21220497]
The full name of the establishment is the (b)(6). Service was not dispatched. Calibration passed on april 3, 2015 with access thyroglobulin antibody ii reagent lot 431463 and calibrator lot 435844. There is no evidence of pre-analytical sample handling issue and no indication that the access thyroglobulin antibody ii 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
| Report Number | 2122870-2015-00284 |
| MDR Report Key | 4766219 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-04-21 |
| Date Mfgr Received | 2015-04-21 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-06-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681361 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS THYROGLOBULIN ANTIBODY II REAGENT |
| Generic Name | IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY |
| Product Code | JNL |
| Date Received | 2015-05-12 |
| Model Number | NA |
| Catalog Number | A32898 |
| Lot Number | 431463 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-12 |