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 2018-02-16 for DIMENSION? RF520 SMN10444895 manufactured by Siemens Healthcare Diagnostics Inc..
[100510615]
The customer contacted siemens customer care center for the discordant depressed low volume mass creatinine kinase (lmmb) serum result on the dimension exl instrument. Quality control was within specification during testing. Siemens headquarters support center (hsc) has completed the investigation of the incident. Hsc evaluated the data provided. The data is consistent with a patient specific lmmb interferent occurring without instrument issues or qc inaccuracy. Complaint patient sample demonstrates a repeatable difference in lmmb recovery when testing serum and plasma samples obtained during the same venipuncture. No product non-conformance was found. Per instructions for use: "patient samples may contain heterophilic antibodies that could react with immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[100510616]
A patient sample demonstrated a repeatable difference in low volume mass creatinine kinase (lmmb) recovery when testing serum and plasma samples obtained during the same venipuncture. A discordant falsely depressed serum result for lmmb was obtained on the patient serum sample and a higher result was obtained on the plasma sample both processed on the dimension exl instrument. The initial serum and plasma results were not reported to the physician. The repeated serum and plasma results correlated with the initial results. The repeat testing on the original serum sample obtained a lower result than the result obtained on the plasma sample. The repeat plasma sample was reported and not questioned. There is no known report of patient intervention or adverse health consequences due to the discordant falsely depressed serum lmmb result
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00068 |
| MDR Report Key | 7278372 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2017-09-20 |
| Date Added to Maude | 2018-02-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 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. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? LMMB MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2018-02-16 |
| Catalog Number | RF520 SMN10444895 |
| Lot Number | FA8263 |
| Device Expiration Date | 2018-09-20 |
| 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 | 2018-02-16 |