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 2018-12-26 for DIMENSION? K7058 SMN 10445904 manufactured by Siemens Healthcare Diagnostics Inc.
[131940615]
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed immunoglobulin m (igm) result. The instructions for use for igm states the following: "monoclonal immunoglobulins may show reactivity different from the polyclonal calibrator, which in isolated cases may lead to artificially decreased or non-linear results". Based on the performed analysis there is no indication that a general product issue exists. The same igm flex wells were used to run other patient samples as well as qc and no further discrepant results were observed. The issue is limited to one specific patient who is known to have a monoclonal component. The cause is unknown. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[131940616]
A discordant, falsely depressed immunoglobulin m (igm) result was obtained on a patient sample on the dimension vista 1500 system. The result was reported to the physician(s). The same sample was reprocessed the same day and a higher result was obtained and a corrected report was issued. There are no known reports of patient intervention or adverse health consequences due to the discordant igm result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00714 |
| MDR Report Key | 8197844 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-04 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2018-12-26 |
| 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 | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? IGM IMMUNOGLOBULIN M FLEX? REAGENT CARTRIDGE |
| Product Code | CFN |
| Date Received | 2018-12-26 |
| Catalog Number | K7058 SMN 10445904 |
| Lot Number | 18173MA |
| Device Expiration Date | 2019-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 500 GBC DRIVE P.O. BOS 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-26 |