MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-15 for DIMENSION RXL MAX WITH HM manufactured by Siemens Healthcare Diagnostics Inc.
[26642413]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse replaced the source lamp and aligned it. The cause of the discordant tacrolimus results on four patient samples was related to a malfunction of the source lamp. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[26642414]
Discordant tacrolimus results were obtained on four patient samples on a dimension rxl max with hm instrument. The discordant results were reported to the physician(s), who questioned them. The samples were repeated on the same instrument, resulting lower for samples (b)(6). The repeat results for samples (b)(6) were not provided by the customer. It is unknown which repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant tacrolimus results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2015-00524 |
| MDR Report Key | 5079319 |
| Date Received | 2015-09-15 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-08-17 |
| Date Mfgr Received | 2015-08-21 |
| Device Manufacturer Date | 2011-01-27 |
| Date Added to Maude | 2015-09-15 |
| 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 | MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| 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 | 0 |
| Brand Name | DIMENSION RXL MAX WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MLM |
| Date Received | 2015-09-15 |
| Model Number | DIMENSION RXL MAX 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 |
| Brand Name | DIMENSION RXL MAX WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-09-15 |
| Model Number | DIMENSION RXL MAX WITH HM |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-15 |