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 2017-05-08 for DIMENSION? RXL MAX WITH HM manufactured by Siemens Healthcare Diagnostics Inc.
[74742531]
The customer contacted the siemens customer care center (ccc) to report the discordant enzymatic carbonate (eco2) result. The customer did not wish to troubleshoot and requested service. The customer provided quality controls (qc) data prior to and after the sample in question, and results were within range. A siemens customer service engineer (cse) was dispatched to the customer site. The cse verified the alignment, ran qc and ran the sample in question three times, which resulted with good precision. The cause of the discordant eco2 result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[74742532]
A discordant, falsely high enzymatic carbonate (eco2) result was obtained on one patient sample on a dimension? Rxl max with hm instrument. The discordant result was not reported to the physician(s). The original sample was repeated on alternative dimension? Rxl instrument and recovered lower. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high eco2 result.
Patient Sequence No: 1, Text Type: D, B5
[76782542]
The initial mdr 2517506-2017-00478 was filed on may 08, 2017. Additional information (05/18/2017): a siemens headquarter support center (hsc) specialist evaluated the data related to the event. The sample was spun in a stat spin for 5 minutes. Stat spins are not recommended by tube vendor. The cause of the sample being centrifuged outside of tube vendor specifications is failure to follow instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00478 |
| MDR Report Key | 6552363 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-08 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-05-18 |
| Device Manufacturer Date | 2010-02-24 |
| Date Added to Maude | 2017-05-08 |
| 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 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 REGISTRATION #:1226181 |
| 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 |
| Generic Name | DIMENSION? RXL MAX WITH HM |
| Product Code | CHS |
| Date Received | 2017-05-08 |
| Model Number | DIMENSION? RXL MAX WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |
| Generic Name | DIMENSION? RXL MAX WITH HM |
| Product Code | JJE |
| Date Received | 2017-05-08 |
| Model Number | DIMENSION? RXL MAX WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-05-08 |