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 2016-05-13 for DIMENSION XPAND PLUS WITH HM manufactured by Siemens Healthcare Diagnostics Inc..
[45163242]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced the sample arm. A siemens headquarter support center (hsc) evaluated the instrument data. Low values on read 3, a measure of the absorbance of hemoglobin before the tacrolimus reaction takes place, are suggestive of lower hemoglobin in the sample which was transferred from the sample cup. Low hemoglobin can occur by short sampling: air bubble in the cup, fluidics issues: transfer of sample from a primary tube within which the red cells have begun to settle. Sample handling would account for an air bubble in the sample container or the poor mixing of the primary tube. Aspiration of the aliquot from high or low in the sample column will have less red cells or elevated red cells respectively. The cause of the discordant, falsely low tacrolimus results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[45163243]
Discordant, falsely low tacrolimus results were obtained on patient samples on a dimension xpand plus with hm instrument. The initial results were not reported to the physician. The samples were repeated on the same instrument, resulting higher. The repeat results were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low tacrolimus results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00273 |
| MDR Report Key | 5653875 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-04-20 |
| Device Manufacturer Date | 2004-11-13 |
| Date Added to Maude | 2016-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MRS. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION XPAND PLUS WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MLM |
| Date Received | 2016-05-13 |
| Model Number | DIMENSION XPAND PLUS WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |