MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-03-06 for ACCESS FERRITIN 33020 manufactured by Chaska Discrete Mfg Io.
[137943521]
Customer did not provide patient demographics such as date of birth, sex, weight, ethnicity or race. The access ferritin reagent was not returned for evaluation. A beckman laboratory system support (lss) was dispatched to the customer's site and performed a dilution test for the questioned sample on (b)(6) 2019 and the test result of the diluted sample was > 75000. 0 ng/ml. The cause of this isolated event cannot be determined. Beckman coulter internal number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137943522]
The customer reported low ferritin results for one patient sample. The result was generated on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)). The initial elevated ferritin result was released from the laboratory and the report was sent to the patient. The patient received treatment based on the initial result on (b)(6) 2019. The details of the treatment were not provided. The patient? S dosage of medication was adjusted after reporting of the second lower result on (b)(6) 2019. The details of the treatment were not provided. The patient was sent for emergency care. On (b)(6) 2019, the patient was diagnosed with hemophagocytic syndrome. The customer did not report any additional change or impact to patient care or treatment in association with this event. The customer reported that quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event. Information on the collection and processing of the patient sample is not available. No issues with sample integrity were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2019-01051 |
| MDR Report Key | 8394289 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-03-06 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2019-03-06 |
| 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 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | CHASKA DISCRETE MFG IO |
| Manufacturer Street | BECKMAN COULTER 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 FERRITIN |
| Generic Name | RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN |
| Product Code | JMG |
| Date Received | 2019-03-06 |
| Model Number | 33020 |
| Catalog Number | 33020 |
| Lot Number | 831328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-06 |