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 2016-10-20 for ACCESS HFSH REAGENT 33520 manufactured by Beckman Coulter Ireland.
[57973201]
The customer did not supply patient's date of birth and weight. There is no evidence that the access hfsh reagent was returned for evaluation. A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site. The customer was advised to send the patient's sample to the beckman coulter complaint handling unit (chu) for evaluation. The marseilles chu received one (1) sample for investigation. The patient's sample was analyzed utilizing the access hfsh assay on the access 2 immunoassay system (serial number (b)(4)). The marseilles chu obtained one (1) elevated result and confirmed customer's results. Further testing of this sample, with blocker proteins, decreased the sample's signal causing a decrease in the access hfsh result by 66%, confirming the presence of a patient source interferent related to heterophile antibodies. In conclusion, the cause of the elevated access hfsh results is due to a patient source interferent related to heterophile antibodies.
Patient Sequence No: 1, Text Type: N, H10
[57973202]
The customer reported obtaining repeatable elevated follicle stimulating hormone (access hfsh) results for one (1) patient involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) that were discordant to the patient's clinical file. The initial access hfsh result recovered above the assay's normal reference range. The customer reanalyzed the patient's sample several additional times (no precision provided) on the same laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and obtained elevated results recovering above the assay's normal reference range again. Due to these elevated access hfsh results, the patient underwent a stimulation test. There was no report of additional change to treatment in conjunction with this event. Calibrations, quality controls (qc) and system checks were performing within assay and instrument specifications. No hardware errors, flags or other assay issues were reported in conjunction with this event. The patient's sample was collected in a serum tube and was centrifuged at 3,000 rpm (rotations per minute) for ten (10) minutes at room temperature. No issues with sample integrity were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680746-2016-00004 |
| MDR Report Key | 6043693 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-20 |
| Date of Report | 2016-09-26 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2016-09-26 |
| Device Manufacturer Date | 2015-12-09 |
| Date Added to Maude | 2016-10-20 |
| 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 | MS. ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER IRELAND |
| Manufacturer Street | MERVUE BUSINESS PARK |
| Manufacturer City | MERVUE, GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS HFSH REAGENT |
| Generic Name | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE |
| Product Code | CGJ |
| Date Received | 2016-10-20 |
| Model Number | NA |
| Catalog Number | 33520 |
| Lot Number | 570257 |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER IRELAND |
| Manufacturer Address | MERVUE BUSINESS PARK MERVUE, GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-20 |