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 2016-11-03 for DIMENSION? DF81 10444984 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[59071255]
Analysis of the instrument data provided indicates that the cause for the depressed igm result is unknown. The reported result of 4535. 42 mg/dl with an assay range/diluted flag was reported to the physician and was questioned. The siemens headquarters support center representative completed an investigation of the incident and concluded that the reported result was accompanied with an assay range flag or assay range/diluted flag indicating the result was above the assay range. Per the dimension rxl max operator's guide, this result is not reportable since it was accompanied by the assay range flag. Qc was within laboratory ranges on the date of testing. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[59071256]
A discrepant depressed immunoglobulin m (igm) result was obtained on a patient sample on the dimension rxl max instrument relative to results on an alternate methodology. The results was reported to the physician who questioned the result. A higher result was obtained on the same sample by the alternate methodology. There is an indication that patient treatment was delayed on the basis of the questioned depressed igm results. A platelet removal treatment was performed one day later on the basis of the higher result obtained on the alternate methodology. There was no report of adverse health consequences as a result of the questioned depressed igm result or the delay in treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00351 |
| MDR Report Key | 6076192 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-03 |
| Date of Report | 2016-11-03 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-10 |
| Device Manufacturer Date | 2016-04-05 |
| Date Added to Maude | 2016-11-03 |
| 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 |
| 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? |
| Generic Name | DIMENSION? IGM IMMUNOGLOBULIN M FLEX? REAGENT CARTRIDGE1500 SYSTEM |
| Product Code | CFQ |
| Date Received | 2016-11-03 |
| Catalog Number | DF81 10444984 |
| Lot Number | DA7095 |
| Device Expiration Date | 2017-04-05 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-03 |