MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-30 for ACCESS THYROGLOBULIN ANTIBODY II REAGENT A32898 manufactured by Beckman Coulter.
[23447464]
A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site. No hardware errors, flags or other assay issues were reported in conjunction with this event. There is no evidence that the access thyroglobulin antibody ii reagent was returned for evaluation. The customer sent the patient's sample to beckman coulter where testing was performed to evaluate the sample for interference. No interference was found. The sample was also was analyzed on a second methodology ((b)(4)) and recovered with a result above the assay's normal reference range. In conclusion, the cause of the event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[23447465]
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 another methodology. The initial access thyroglobulin antibody ii result was within the normal reference range of the assay. The customer analyzed the patient's sample on an alternate methodology ((b)(4)) and 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. Beckman coulter (bec) cf originator recommended that the customer provide the patient sample for testing by the bec complaint handling unit (chu). Calibration, qc (quality control) and system check parameters were all recovering within expected ranges at the time of the event. Information on the collection and centrifugation of the patient sample was not supplied. There was no report of sample integrity issues reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2015-00458 |
| MDR Report Key | 4953539 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-07-02 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Brand Name | ACCESS THYROGLOBULIN ANTIBODY II REAGENT |
| Generic Name | IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY |
| Product Code | JNL |
| Date Received | 2015-07-30 |
| Catalog Number | A32898 |
| Lot Number | 438550 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | I |
| 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 | 2015-07-30 |