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 2017-02-07 for DIMENSION? DIMENSION? EXL WITH LM SMN 10472176 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[66681551]
The customer contacted the siemens customer care center (ccc). The cause of the discordant amm results is unknown. The issue was resolved by replacement of the flex reagent cartridge with an alternate amm flex reagent cartridge lot and repeat testing. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[66681552]
Discordant low ammonia (amm) results were obtained on a patient sample on the dimension exl system. The patient result was not reported to the physician. The sample was rerun on the same sample on the same instrument after a flex reagent cartridge change and a higher result was obtained and reported. There are no reports of patient intervention or adverse health consequences as a result of the discordant amm results.
Patient Sequence No: 1, Text Type: D, B5
[73363322]
Original mdr 2517506-2017-00135 was filed 2/7/2017. Siemens healthcare diagnostic headquarters support center evaluated the incident and concluded their investigation. The cause of the discordant low ammonia results is unknown. There was only one patient sample affected. The data logs from the instrument were analyzed. The low results were processed using flex lot fa7096. There was no indication in the data logs of reagent delivery, foaming, or hemolysis interference based on result monitors for the tests processed using either lot fa7096 or the flex lot fa7123 used for the repeat tests. No systemic instrument or reagent malfunction was confirmed. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00135 |
| MDR Report Key | 6307017 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-07 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2014-04-11 |
| Date Added to Maude | 2017-02-07 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Street | REGISTRATION NUMBER 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? |
| Generic Name | DIMENSION? EXL WITH LM INTEGRATED CHEMISTRY SYSTEM |
| Product Code | JIF |
| Date Received | 2017-02-07 |
| Model Number | DIMENSION? EXL WITH LM |
| Catalog Number | SMN 10472176 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? EXL WITH LM INTEGRATED CHEMISTRY SYSTEM |
| Product Code | JJE |
| Date Received | 2017-02-07 |
| Model Number | DIMENSION? EXL WITH LM |
| Catalog Number | SMN 10472176 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |