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 2017-04-21 for DIMENSION RXL MAX WITH HM INSTRUMENT manufactured by Siemens Healthcare Diagnostics Inc.
[73393805]
The customer contacted the siemens customer care center (ccc). Quality controls were within range, there were no instrument errors, and system checks passed. The cause of the discordant, falsely low ldi result is unknown, as the sample resulted as expected when repeated on the same instrument. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[73393806]
A discordant, falsely low lactate dehydrogenase (ldi) result was obtained on one patient sample on a dimension rxl max with hm instrument. The discordant result was reported to the physician(s). The sample was repeated on the same instrument and on other dimension instruments to confirm the result, which resulted higher than the initial result. The corrected result was reported to the physician(s). There are no reports of adverse health consequences due to the discordant, falsely low lactate dehydrogenase (ldi).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00435 |
| MDR Report Key | 6510973 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2008-10-16 |
| Date Added to Maude | 2017-04-21 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION #: 1226181 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 RXL MAX WITH HM INSTRUMENT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-04-21 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION RXL MAX WITH HM INSTRUMENT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-21 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-21 |