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 2016-04-08 for DIMENSION? CLINICAL CHEMISTRY SYSTEMS RF420, SMN10444904 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[42224352]
The cause of the falsely elevated mmb results is unknown. After the customer observed elevated results on four patient samples and found that level 1 qc was out, customer migrated to a new reagent cartridge, reran qc and confirmed it was within range, and repeated the samples. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[42224353]
Discordant elevated mass creatine kinase (mmb) results were obtained on four patient samples on the dimension exl system and results were reported. The laboratory decided to check qc and level 1 qc was high. The samples were repeated on a new reagent cartridge and lower results were obtained. Corrected reports were sent. Patient treatment was not altered or prescribed on the basis of the discordant elevated mass creatine kinase (mmb) results. There was no report of adverse health consequences as a result of the discordant elevated mass creatine kinase (mmb) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00227 |
| MDR Report Key | 5564325 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-03-30 |
| Device Manufacturer Date | 2015-10-05 |
| Date Added to Maude | 2016-04-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY SYSTEMS |
| Generic Name | MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2016-04-08 |
| Catalog Number | RF420, SMN10444904 |
| Lot Number | FB6279 |
| Device Expiration Date | 2016-10-05 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-08 |