MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for BN PROSPEC? SYSTEM 10444804 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[60874416]
The cause of the discrepant flc results is an instrument malfunction of the diluent pump. The customer runs igg subclasses with a siemens reagent and measures free light chain (flc) kappa and lambda with the non-siemens binding site reagent on the bn prospec. The siemens igg subclasses reagents were showing qc results out of laboratory ranges but some of the flc qc was within laboratory limits. No instrument errors were logged. The customer went ahead and ran all flc patients and released the results to the doctor while the analyser was failing the diluent pump calibration. As no error was displayed, the operator continued running the analyser reporting out incorrect results for the binding site flc kappa and lambda. A field engineer replaced the diluent pump and returned the instrument to service. The instrument is performing within specifications. No further evaluation of the device is required. An original mdr was filed on 2016-10-29 under the number 2517506-2016-00396. A supplemental mdr has been filed to that mdr to correct an error in sections d3 (manufacturer name, city and state) and g1,g2 (continued) (manufacturing site address/phone for devices) to correct the manufacturer site that was erroneously entered. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60874417]
Discrepant free light chain (flc) results (kappa and lambda) were obtained on patient samples with the binding site flc reagent on the bn prospec instrument. The results were reported to the physician who questioned the results. After an instrument malfunction was identified and repaired, the same samples were repeated and corrected results were issued. There is no indication that patient treatment was altered or prescribed on the basis of the discrepant flc kappa and lambda results. There was no report of adverse health consequences as a result of the discrepant flc kappa and lambda results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00036 |
| MDR Report Key | 6116853 |
| Date Received | 2016-11-21 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-09-26 |
| Date Mfgr Received | 2016-09-29 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2016-11-21 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BN PROSPEC? SYSTEM |
| Generic Name | BN PROSPEC? SYSTEM |
| Product Code | JZW |
| Date Received | 2016-11-21 |
| Model Number | BN PROSPEC |
| Catalog Number | 10444804 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-21 |