MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-12-31 for ACCESS THYROGLOBULIN 33860 manufactured by Chaska Discrete Mfg Io.
[131723790]
The customer did not provide patient demographics such as date of birth, weight, ethnicity or race. The access thyroglobulin reagent was not returned for evaluation. All assay and system verifications met specifications at the time of this incident. No hardware errors, flags or other assay issues were reported in conjunction with this event. One patient sample was sent to the beckman coulter complaint handling unit (chu) for investigation. Patient sample was first tested neat after centrifugation for the access thyroglobulin assay. The chu obtained a high access thyroglobulin result. Customer's results were therefore confirmed. An interference testing, using different blockers, was then carried out. The blockers used in the interference testing are animal derived antibodies. Scavenger alp, a blocker related to alkaline phosphatase, was also tested. Interference antibodies interaction are listed in the limitations section of the access thyroglobulin instructions for use. This interference testing demonstrated the presence of interfering substances since animal derived antibodies used in the test significantly lowered the signal. The cause of this event is a patient source interferent.
Patient Sequence No: 1, Text Type: N, H10
[131723791]
On (b)(6) 2018 the customer reported that reproducible elevated thyroglobulin (access thyroglobulin) results had been generated on the customer's unicel dxi 800 access immunoassay system (serial number (b)(4)) for one patient. The elevated access thyroglobulin results were released from the laboratory. The patient's samples were analyzed utilizing other methodologies and recovered with negative results. Actual results were not provided. There was a report of change to patient care or treatment which occurred in connection with this event. The patient underwent mri (magnetic resonance imaging). There was no report of further injury or change to patient management reported in this event. Calibration, quality control and system check were all performing within specifications at the time of the incident. Information regarding patient sample collection and processing was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2018-01037 |
| MDR Report Key | 8206504 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-11-30 |
| Date Facility Aware | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-12-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| 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 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Product Code | MSW |
| Date Received | 2018-12-31 |
| Model Number | 33860 |
| Catalog Number | 33860 |
| Lot Number | 724117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHASKA DISCRETE MFG IO |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-31 |