MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-08 for N LATEX ADNASE B OWTI manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[18252109]
A falsely depressed anti-streptococcal dnase b (adnase b) result was reported on a patient sample. The result was reported to the physician who questioned the result. The sample was re-run and a higher result was obtained in line with physician expectations. Patient treatment was not altered or prescribed on the basis of the falsely depressed adnase b result. There is no report of adverse outcome to patients as a result of falsely depressed adnase b result.
Patient Sequence No: 1, Text Type: D, B5
[18458197]
The cause of the falsely depressed adnase b result was sample integrity. The n latex adnase b ifu states: serum samples must be completely coagulated and, after centrifugation, must not contain any particles or traces of fibrin. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2012-00014 |
| MDR Report Key | 2775448 |
| Report Source | 05,06 |
| Date Received | 2012-10-08 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-09-06 |
| Date Mfgr Received | 2012-09-11 |
| Device Manufacturer Date | 2012-03-22 |
| Date Added to Maude | 2013-01-23 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N LATEX ADNASE B |
| Generic Name | N LATEX ADNASE B |
| Product Code | GTR |
| Date Received | 2012-10-08 |
| Catalog Number | OWTI |
| Lot Number | 41601 |
| Device Expiration Date | 2013-01-19 |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-08 |