MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-07-18 for DIMENSION? FERRITIN FLEX? REAGENT CARTRIDGE RF440 SMN10444946 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[49757515]
Analysis of instrument data by siemens healthcare diagnostics indicates that the cause for the falsely depressed ferritin (ferr) result was a hook effect. The customer was inquiring about a low unflagged result. The dimension ferr instructions for use (ifu) addresses the potential for hook effect. It states: "one-step sandwich immunometric assays are susceptible to a high-dose "hook effect," where an excess of antigen prevents simultaneous binding of the capture and detection antibodies to a single analyte molecule. Such samples must be diluted and reassayed prior to reporting the results. The ferr method shows no hook effect up to at least 100,000 ng/ml ferritin. " in this instance, the patient sample true results exceeded 100,000 and a discrepant result was unflagged for high absorbance. The reagent is performing within ifu claims. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[49757516]
A falsely depressed ferritin (ferr) result was obtained on a patient sample. The result was reported to the physician. The sample was repeated and a higher result was obtained in concordance with prior patient ferr results and physician expectation. Patient treatment was altered on the basis of the falsely depressed ferr result. A planned medical procedure was postponed. The nature of the procedure was not disclosed. There was no report of adverse health consequences as a result of the falsely elevated ferr result or the procedure postponement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00281 |
| MDR Report Key | 5801841 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-18 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-06-26 |
| Date Mfgr Received | 2016-06-27 |
| Device Manufacturer Date | 2016-04-14 |
| Date Added to Maude | 2016-07-18 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? FERRITIN FLEX? REAGENT CARTRIDGE |
| Generic Name | DIMENSION? FERR FERRITIN FLEX? REAGENT CARTRIDGE |
| Product Code | JMG |
| Date Received | 2016-07-18 |
| Catalog Number | RF440 SMN10444946 |
| Lot Number | DA7104 |
| Device Expiration Date | 2017-04-14 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-18 |